Mayumi™ Thrombectomy System

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 3, 2026 MicroVention, Inc., d/b/a Terumo Neuro Remya Krishnan Senior Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656 Re: K254035 Trade/Device Name: Mayumi™ Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA Dated: July 31, 2026 Received: August 3, 2026 Dear Remya Krishnan: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254035 - Remya Krishnan Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, KRINA M. PATEL -S Digitally signed by KRINA M. PATEL -S Date: 2026.09.03 14:00:04 -04'00' For, Gregory O'Connell Assistant Director DHT2C: Division of Coronary {2} K254035 - Remya Krishnan Page 3 and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254035 | ? | | Please provide the device trade name(s). | | ? | | Mayumi™ Thrombectomy System | | | | Please provide your Indications for Use below. | | ? | | The Mayumi Thrombectomy System is indicated for: •The non-surgical removal of emboli and thrombi from blood vessels •Injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel The Mayumi Thrombectomy System is intended for use in the peripheral vasculature. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} 510(k) #: K254035 # 510(k) Summary Prepared on: 2026-09-02 ## Contact Details 21 CFR 807.92(a)(1) Applicant Name MicroVention, Inc.,d/b/a Terumo Neuro Applicant Address 35 Enterprise Aliso Viejo CA 92656 United States Applicant Contact Telephone 949-434-4610 Applicant Contact Remya Krishnan, PhD Applicant Contact Email remya.krishnan@microvention.com ## Device Name 21 CFR 807.92(a)(2) Device Trade Name Mayumi™ Thrombectomy System Common Name Embolectomy catheter Classification Name Aspiration Thrombectomy Catheter Regulation Number 870.5150 Product Code(s) QEZ; KRA ## Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213402 Triever24, Triever20 QEW; KRA ## Device Description Summary 21 CFR 807.92(a)(4) The Mayumi™ Thrombectomy System is a single-use, sterile, non-pyrogenic medical device designed for use in peripheral vasculature and available in two configurations – the 20Fr and the 24Fr systems based on the Aspiration Catheter outer diameter (OD). The Mayumi system consists of the following components, packaged together: - Mayumi Aspiration Catheter (20Fr or 24Fr) - 60 cc Locking Syringe - Dilator - Y-Connector ## Intended Use/Indications for Use 21 CFR 807.92(a)(5) The Mayumi Thrombectomy System is indicated for: - The non-surgical removal of emboli and thrombi from blood vessels - Injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel The Mayumi Thrombectomy System is intended for use in the peripheral vasculature. ## Indications for Use Comparison 21 CFR 807.92(a)(5) Both subject and the predicate devices have the same indications for use in the peripheral vasculature* {5} *Mayumi does not intend to claim indications for use in the treatment of pulmonary embolism as part of the current submission. ## Technological Comparison 21 CFR 807.92(a)(6) -Both the subject and predicate devices have same design for catheter sizes (20F and 24F), proximal and distal metal structures made of stainless steel, proximal and distal jacket material made of PEBAX, straight tip configuration and a 0.035' guidewire compatibility. Both devices use a 60cc Locking Syringe made of polycarbonate as the aspiration source. -Both the subject and predicate devices have same principles of operations defined as a single-use, over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. -Both the subject and predicate devices have a similar mode of action. The catheter along with the provided dilator are inserted and advanced to the thrombus over a pre-placed 0.035' guidewire. After removal of its dilator, thrombus is removed by aspiration with the provided 60cc Locking syringe. After the procedure is complete, the aspiration catheter is removed from the patient. -It is important to note that technological differences for mode of action between the devices is that FlowTriever Catheters can be used for mechanical thrombectomy by deploying directly through the Triever20, or Triever24 catheters. The Triever Catheters can also be used as a stand-alone device for vacuum assisted aspiration, which is the primary mode of action for the subject device, Mayumi and for which the substantial equivalence is claimed. A detailed comparison to support substantial equivalence to the predicate is provided herein: | | Triever24; Triever20 (Predicate Device cleared under K213402) | Mayumi™ Thrombectomy System (Subject Device) | Equivalency Claim (Same/Similar) | | --- | --- | --- | --- | | **Intended Use/ Indications for Use** | The FlowTriever Retrieval/Aspiration System is indicated for: • The non-surgical removal of emboli and thrombi from blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever Catheters are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters. | The Mayumi Thrombectomy System is indicated for: • The non-surgical removal of emboli and thrombi from blood vessels • Injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel The Mayumi Thrombectomy System is intended for use in the peripheral vasculature. | Same Note: Mayumi does not extend claim for intended use in the treatment of pulmonary embolism or treating clot in transit in the right atrium. | | **Product Code** | Primary Product code: QEW Secondary Product code: KRA | Primary Product code: **QEZ** Secondary Product code: **KRA** | Similar | | **Product Classification** | Class II | Class II | Same | | **Product Regulation** | 21CFR 870.5150 | 21CFR 870.5150 | Same | Page 2 of 5 {6} | | Triever24; Triever20 (Predicate Device cleared under K213402) | Mayumi™ Thrombectomy System (Subject Device) | Equivalency Claim (Same/Similar) | | --- | --- | --- | --- | | **Regulation Description** | Embolectomy catheter | Embolectomy catheter | Same | | **Regulation Medical Specialty** | Cardiovascular | Cardiovascular | Same | | **Principle of Operation** | The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. | The Mayumi Thrombectomy System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. | Same Note: Mayumi does not extend claim for intended use in the treatment of pulmonary embolism. | | **Mode of Action** | Triever24 and Triever20 provide a conduit for aspiration and clot removal. It consists of a single lumen catheter with a proximal hemostasis valve and stopcock with a flush port. A radiopaque marker is positioned near the distal tip to aid with fluoroscopic navigation. A Dilator compatible with a 0.035' guidewire is provided for the Triever24 and Triever20 to aid with insertion. A 60 cc Locking Syringe is provided to create a vacuum for removal of clots. | The Mayumi Aspiration Catheter provides a conduit for aspiration and clot removal. It consists of a single lumen catheter with a proximal hemostasis valve, stopcock and quick release fitting for syringe attachment and detachment. A radiopaque marker is positioned near the distal tip to aid fluoroscopic navigation. A radiopaque Dilator compatible with a 0.035' guidewire is provided for the Aspiration Catheter to aid with insertion. A 60 cc Locking Syringe is provided to create a vacuum for removal of clots. | Same | | **Vacuum Aspiration Source** | 60cc Large Bore Syringe | 60cc Large Bore Syringe | Same | | **System Configuration** | | | | | **Key components** | - Aspiration Catheter (20 Fr or 24 Fr) - 60 cc Locking Syringe - Dilator | - Mayumi Aspiration Catheter (20 Fr or 24 Fr) - 60 cc Locking Syringe - Dilator - Y-Connector | Similar Note: Mayumi is packaged with an additional Y-connector, to attach to the proximal Luer connector on the Dilator to flush the Dilator and to prevent blood loss. | | **Catheter Tip Configuration** | Straight | Straight | Same | | **Target Vessel** | < 8mm | < 8mm | Same | | **Catheter Size(s)** | 20F; 24F | 20F; 24F | Same | | **Catheter Inner Diameter (ID)** | 0.220 in (20Fr) 0.271 in (24Fr) | 0.221 in (20Fr) 0.272 in (24Fr) | Similar | | **Catheter Outer Diameter (OD)** | 0.256 in (20Fr) 0.299 in (24Fr) | 0.260 in (20Fr) 0.312 in (24Fr) | Similar | Page 3 of 5 {7} | | Triever24; Triever20 (Predicate Device cleared under K213402) | Mayumi™ Thrombectomy System (Subject Device) | Equivalency Claim (Same/Similar) | | --- | --- | --- | --- | | **Effective Catheter Length** | 90cm (20Fr) 90cm (24Fr) | 100 cm (20Fr) 100 cm (24Fr) | Similar | | **Guidewire Compatibility** | 0.035" guidewire | 0.035" guidewire | Same | | **Dilator Working Length** | ~100cm | ~112cm | Similar | | **Materials of Construction** | | | | | **Proximal Metal Structure** | Stainless Steel Braid | Stainless Steel Braid | Same | | **Distal Metal Structure** | Stainless Steel Coil | Stainless Steel Coil | Same | | **Proximal/Distal Jacket Material** | Polyether block amide (PEBAX) | Polyether block amide (PEBAX) | Same | | **Catheter and Dilator system material** | Proprietary thermoplastic | Proprietary thermoplastic | Similar | | **Syringe Material** | Polycarbonate | Polycarbonate | Same | | **Coating** | Catheter: No coating identified Dilator: Proprietary coating/ material | Catheter: Hydrophilic coating Dilator: Hydrophilic coating | Similar | | **Other** | | | | | **Device Categorization per ISO 10993-1** | Externally Communicating Medical Device <24hours limited contact duration | Externally Communicating Medical Device <24hours limited contact duration | Same | | **Sterilization** | SAL 10^{-6}; EtO [Ethylene Oxide] | SAL 10^{-6}; EtO [Ethylene Oxide] | Same | | **Method of Supply** | Single use; Sterile | Single use; Sterile | Same | ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) The following bench testing were performed for the subject device, Mayumi: 1. 1) Device compatibility (ISO 11070 and ISO 80369-7) 2. 2) Physical Attributes (ISO 10555-1) - • Effective working length - • Distal ID/ OD at Marker Band - • Proximal ID/OD - • OD of Coil/Braid 3. 3) Aspiration Effectiveness- Suction Volume 4. 4) Shaft Performance tests - • Distal Kink Test - • Distal Tip Deflection Test 5. 5) System Trackability 6. 6) Catheter lumen collapse test during aspiration 7. 7) System Leakage (ISO 10555-1) 8. 8) Force at Break (ISO 10555-1) 9. 9) Particulate testing 10. 10) Coating Durability (ISO 10555-1 and AAMI/TIR42) 11. 11) Connector Locking/Unlocking Force 12. 12) Catheter Connector Valve and Syringe Connector Durability Page 4 of 5 {8} 13) Mayumi Simulated Use Study 14) Radiopacity Test 15) Comparative clot aspiration testing 16) Torque and Burst Characterization The following biocompatibility testing was conducted in accordance with ISO-10993-1: • Cytotoxicity • Sensitization • Acute systemic toxicity • Material Mediated Pyrogenicity • Intracutaneous Reactivity • Hemolysis • Complement Activation • Thrombogenicity The Mayumi Thrombectomy System was subjected to GLP in-vivo animal testing that confirmed the device did not raise questions related to safe use. No clinical studies were performed. The subject device, Mayumi Thrombectomy System performed equivalent to the comparator device InariTriever24 and Triever20 catheters, in terms of device trackability, aspiration performance, etc. The passing results from the acute animal studies and performance bench testing are considered sufficient to support the intended use of the Mayumi Thrombectomy System. Minor technological differences between the subject and predicate devices do not raise different questions of safety, performance and effectiveness. The subject and predicate devices are therefore considered to be substantially equivalent for the claimed intended use. MicroVention (d/b/a Terumo Neuro) concludes through a review of the benchtop and non-clinical animal assessments, comparison of the device classification, indications for use, operating principle, technological characteristics and biocompatibility that the Mayumi™ Thrombectomy System is substantially equivalent to the predicate Inari Triever24 and Triever20 catheters cleared under K213402. Any differences between the subject device and the predicate device do not raise different questions of safety and effectiveness. Page 5 of 5