Euphora Rapid Exchange (RX) Balloon Dilatation Catheter

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION July 27, 2026 Medtronic Ireland Sarah Grant Senior Regulatory Affairs Specialist Parkmore Business Park W. Galway, H91 VY19 Ireland Re: K261759 Trade/Device Name: Euphora Rapid Exchange (RX) Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (Ptca) Catheter Regulatory Class: Class II Product Code: LOX Dated: May 28, 2026 Received: May 28, 2026 Dear Sarah Grant: 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} K261759 - Sarah Grant 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} K261759 - Sarah Grant 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, JENNY R. KATSNELSON -S Digitally signed by JENNY R. KATSNELSON -S Date: 2026.07.27 18:20:05 -04'00' for 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: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K261759 Device Name Euphoria Rapid Exchange (RX) Balloon Dilatation Catheter Indications for Use (Describe) The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter (balloon models 2.00 mm to 4.00 mm) is also indicated for postdeployment expansion of balloon expandable stents. 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 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K261759 Page 1 of 4 ## 510(k) Summary per 21 CFR 807.92 | Submitter: | Medtronic Ireland Parkmore Business Park West Galway Ireland H91 VY19 | | --- | --- | | Contact Name(s): | (1) Sarah Grant Senior Regulatory Affairs Specialist Email: sarah.grant@medtronic.com (2) Denise Keehan Principal Regulatory Affairs Specialist Email: denise.keehan@medtronic.com | | Date Prepared: | July 27, 2026 | | Trade Name: | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | | Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | | Device Classification: | Class II | | Classification Name: | Catheters, Transluminal Coronary Angioplasty, Percutaneous | | Classification Panel: | Cardiovascular | | Classification Regulation: | 21 CFR 870.5100 | | Product Code: | LOX | {5} K261759 Page 2 of 4 # **Predicate Device:** | Predicate Device Clearance/Approval # | Predicate Device Name | Clearance Date | | --- | --- | --- | | K143480 | Euphora Rapid Exchange Balloon Dilatation Catheter | April 2, 2015 | # **Device Description:** Euphora Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) device. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure as defined in the product labelling. The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guidewire to position the catheter. Radiopaque balloon marker bands enable accurate placement. Shaft markers for brachial and femoral techniques are in place. # **Indications For Use:** The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter (balloon models 2.0 mm - 4.0 mm) is also indicated for postdeployment expansion of balloon expandable stents. # **Comparison of Technological Characteristics with the Predicate Device** Euphora Rapid Exchange Balloon Dilatation Catheter has the same indication for use and principals of operation as the legally marketed predicate device (K143480). The technological and functional characteristics are substantially equivalent to the predicate device, in terms of design, dimensions and method of construction. Technological characteristics differ only with respect to the PTFE based, non-hydrophilic material change on the proximal shaft assembly. There are no other technological characteristic differences compared to the predicate device. All other device materials remain identical. The purpose of the material is not changing as a result of this modification. The material difference does not introduce any new questions of safety or effectiveness compared to the predicate; the device continues to meet its intended use. # **Comparison to Predicate Devices** The subject device is substantially equivalent to the predicate device, which is Medtronic's own legally market device and is substantially equivalent. There is no change in sterilization method, sterility assurance level and shelf life. The material difference does not introduce different questions of safety or effectiveness compared to the predicate. {6} K261759 Page 3 of 4 ## Summary of Non-Clinical Data The following non-clinical tests were performed to evaluate and demonstrate substantial equivalence between the subject device and the predicate device. Biocompatibility Evaluation (conducted per ISO 10993 standards): - Physical Information & Chemical Information (GlideMed Coating Formulation) - Toxicological Risk Assessment - Cytotoxicity - Acute Systemic Toxicity - Hemocompatibility - Hemolysis - Complement Activation - Partial Thromboplastin Time (PTT) - Platelet/Leucocyte Count - Guinea Pig Maximization Sensitization - Intracutaneous Irritation - *In vitro* Skin Irritation - Material Mediated Pyrogenicity Performance Testing included: - Hypotube Bond Outer Diameter - Proximal Shaft Outer Diameter - Hypotube/Transition Shaft Tensile - Balloon Preparation, Deployment and Retraction - PTFE Particulate Characterization Testing - PTFE Durability Characterization Testing All test results met the acceptance criteria, which are consistent with the predicate device, demonstrating that the subject device meets established performance specifications and is suitable for its intended use. The results confirmed that the device is substantially equivalent to the predicate. ## Summary of Clinical Data {7} K261759 Page 4 of 4 No clinical testing was required for this 510(k) submission. ### Conclusion from Data The differences between the subject device and predicate device have been evaluated through non-clinical testing, which demonstrates that the subject device is substantially equivalent to the predicate device.