CrossFAST Integrated Microcatheter Advanced Delivery System

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 18, 2026 Vantis Vascular, Inc. Mai-Ly Wilcox VP of Regulatory and Quality Affairs 2570 N First St. Suite 200 San Jose, California 95131 Re: K262817 Trade/Device Name: CrossFAST Integrated Microcatheter Advanced Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 7, 2026 Received: August 7, 2026 Dear Mai-Ly Wilcox: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262817 - Mai-Ly Wilcox Page 2 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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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- {2} K262817 - Mai-Ly Wilcox Page 3 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, LYDIA S. GLAW -S Digitally signed by LYDIA S. GLAW -S Date: 2026.09.18 15:29:29 -04'00' Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K262817 Device Name CrossFAST Integrated Microcatheter Advanced Delivery System Indications for Use (Describe) The CrossFAST Integrated Microcatheter Advanced Delivery System is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} 510(k) #: # 510(k) Summary Prepared on: 2026-08-07 Contact Details 21 CFR 807.92(a)(1) | Applicant Name | Vantis Vascular, Inc. | | --- | --- | | Applicant Address | 2570 N First St. Suite 200 San Jose CA 95131 United States | | Applicant Contact Telephone | 415-254-1930 | | Applicant Contact | Ms. Mai-Ly Wilcox | | Applicant Contact Email | mwilcox@vantisvascular.com | Device Name 21 CFR 807.92(a)(2) | Device Trade Name | CrossFAST™ Integrated Microcatheter Advanced Delivery System (CFM60) | | --- | --- | | Common Name | Percutaneous catheter | | Classification Name | Catheter, Percutaneous | | Regulation Number | 870.1250 | | Product Code(s) | DQY | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | --- | --- | --- | | K242276 | CrossFAST™ Integrated Microcatheter Advanced Delivery System (CFM55) | DQY | Device Description Summary 21 CFR 807.92(a)(4) CrossFAST™ Integrated Microcatheter Advanced Delivery System (CFM60) ("Device", "CrossFAST", "CrossFAST (CFM60)") is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices. It is intended for use in a cardiac catheterization laboratory by physicians trained in percutaneous, intravascular techniques and procedures. CrossFAST (CFM60) consists of two catheters: an Inner Catheter and an Outer Catheter. The Outer Catheter is intended to act as an extension to a traditional guide catheter (i.e., "guide extension") and to facilitate delivery of interventional devices within the target vasculature. The Inner Catheter is intended to be pre-loaded into the Outer Catheter by the user and to provide additional support to the Outer Catheter during delivery. Once assembled, the Inner Catheter tip extends 3cm beyond the Outer Catheter tip. After the Outer Catheter has been delivered to the target vasculature, the Inner Catheter is removed from the Outer Catheter to allow for the passage of interventional devices. The Device is designed for use in vessels larger than 2.5mm and is not for use in the neurovasculature or the venous system. The Device is single use and provided sterile via Ethylene Oxide (EO) sterilization. The Device is compatible with standard, off-the-shelf 0.014" lumen inner diameter (ID) and minimum 180cm length guidewires and a minimum 100cm length 6F guide catheters. The Device is intended for use with a hemostasis valve. Intended Use/Indications for Use 21 CFR 807.92(a)(5) The CrossFAST™ Integrated Microcatheter Advanced Delivery System is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices. {5} | Indications for Use Comparison | 21 CFR 807.92(a)(5) | | --- | --- | | The CrossFAST™ Integrated Microcatheter Advanced Delivery System (CFM60) has the same Indications for Use as the predicate device, CrossFAST™ Integrated Microcatheter Advanced Delivery System (CFM55). The modifications do not change the intended use or introduce a new intended use. | | | Technological Comparison | 21 CFR 807.92(a)(6) | | The CrossFAST™ Integrated Microcatheter Advanced Delivery System (CFM60) has the same fundamental scientific technology, operating principle, materials of construction, manufacturing processes, sterilization method, and packaging configuration as the predicate device, CrossFAST™ Integrated Microcatheter Advanced Delivery System (CFM55). The subject device incorporates limited dimensional refinements while maintaining the same intended use and compatibility with a 6 Fr guide catheter. Design verification and validation testing demonstrated that these modifications do not raise different questions of safety or effectiveness. | | | Non-Clinical and/or Clinical Tests Summary & Conclusions | 21 CFR 807.92(b) | | The technological differences between the subject and predicate devices have been evaluated through design verification and validation testing and a biocompatibility assessment to provide evidence of substantial equivalence for the CrossFAST (CFM60). Testing previously conducted on the predicate device that is unaffected by the modifications was leveraged in support of this submission. The testing assessed for CrossFAST (CFM60) is listed below. | | | Design Verification and Validation/In-Vitro (Bench) Testing: 1) Visual and Dimensional Testing 2) Tensile Testing (including Simulated Use) 3) Track Force Testing (including Simulated Use) 4) Performance Testing: • System Preparation & Inspection Testing • Stent Passage Testing (including Simulated Use) • Catheter Kink Resistance Testing • Catheter Torque Resistance Testing (including Simulated Use) • Contrast Delivery Testing • Corrosion Resistance Testing • Radiopacity Testing 5) Particulate Testing (including Simulated Use) 6) Coating Characterization • Baseline Coating Integrity • Post Simulated Use Coating Integrity 7) Design Validation & HFE Summative Testing | | | Biocompatibility Assessment: A biocompatibility assessment was performed for the CrossFAST (CFM60). The subject device does not introduce new or changed patient-contacting materials, primary packaging, or manufacturing processing aids as compared to the predicate device. The assessment confirmed that the biocompatibility data previously established for the predicate device remain applicable to the subject device, and that no additional biocompatibility testing was required. | | | Sterilization, Packaging, and Shelf Life: The sterilization method, packaging configuration, and shelf life of the subject device are unchanged from the predicate device. The sterilization, packaging, and shelf-life validations previously conducted on the predicate device were therefore leveraged, and no additional validation was required. | | | No clinical testing was conducted to support this 510(k) Premarket Notification. | | | The non-clinical testing demonstrated that the subject device functions as intended for its intended use and Indications for Use, which are unchanged from the predicate device, and confirmed that any technological differences between the subject device and the selected predicate device do not raise different questions of safety or effectiveness. The test results support that the subject device is substantially equivalent to the predicate device for the same intended use. | |