The FLASH Flex™ Aorto-Ostial Angioplasty System is indicated for the post-delivery expansion of balloon expandable stents within the coronary vasculature.
Device Story
FLASH Flex™ Aorto-Ostial Angioplasty System is a rapid exchange (RX) dual balloon catheter system; used for post-delivery expansion of balloon-expandable stents in coronary vasculature. Device includes pressure relief feature to prevent proximal balloon over-pressurization; compatible with 0.014” guidewires and 6 Fr guide catheters. Operated by physicians in clinical settings; includes 20cc locking syringe for inflation/deflation. Design enhancements include improved tip flexibility, catheter trackability, and Fluorosaver™ markers to reduce radiation exposure. Device functions by inflating balloons to expand stents; output is mechanical expansion of stent within artery. Benefits include improved stent apposition and reduced radiation exposure for operators.
Clinical Evidence
Bench testing only. Performance testing included visual/dimensional, tensile/bond strength, torque, burst pressure, balloon fatigue, drop, package, fluid leak, and simulated use testing. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, and comprehensive hemocompatibility/thrombosis assays. All tests met pre-defined acceptance criteria. No clinical or animal data provided.
Technological Characteristics
Rapid exchange dual balloon catheter. Materials: medical-grade nylon, Pt/Ir, stainless steel, polycarbonate, silicone, cyanoacrylate. Compatible with 0.014" guidewires and 6 Fr guide catheters. Includes pressure relief feature and Fluorosaver™ markers. Sterilization: Ethylene Oxide (EO).
Indications for Use
Indicated for post-delivery expansion of balloon expandable stents within the coronary vasculature.
Regulatory Classification
Identification
Standard PTCA Catheter: A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion. Cutting/scoring PTCA Catheter: A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.
Special Controls
*Classification.* Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
*Cutting/scoring PTCA Catheter* —(1)*Identification.* A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
*Classification.* Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 2, 2026
Verge Medical, Inc.
% Reynier Jacinto
Principal Regulatory Consultant
Bridge City Regulatory, LLC
5331 S Macadam Ave.
Suite 258, Pmb #708
Portland, Oregon 97239
Re: K254022
Trade/Device Name: FLASH Flex™ Aorto-Ostial Angioplasty System
Regulation Number: 21 CFR 870.5100
Regulation Name: Percutaneous Transluminal Coronary Angioplasty (Ptca) Catheter
Regulatory Class: Class II
Product Code: LOX
Dated: February 27, 2026
Received: March 2, 2026
Dear Reynier Jacinto:
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
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K254022 - Reynier Jacinto
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 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-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).
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K254022 - Reynier Jacinto
Page 3
Sincerely,
Jenny R. Katsnelson -S
Digitally signed by Jenny R. Katsnelson -S
Date: 2026.04.02 08:59:22 -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
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| 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) K254022 | |
| Device Name Flash Flex Aorto-Ostial Angioplasty System | |
| Indications for Use (Describe) Flash Flex Aorto-Ostial Angioplasty system is indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature. | |
| 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." | |
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K254022
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510(k) Summary
[per 21 CFR 807.87(h) and 21 CFR 807.92]
MEDICAL
747 Camden Avenue, Suite A, Campbell, CA 95008 USA
FLASH Flex™ Aorto-Ostial Angioplasty System
510(k): K254022
Date Prepared: 15 DEC 2025
Submitter: Verge™ Medical, Inc.
747 Camden Avenue, Suite A
Campbell, CA 95008, USA
Contact: Jon Bohane, GM and COO
Tel: 844-352-7411
Device Name: FLASH Flex™ Aorto-Ostial Angioplasty System
Predicate Device: FLASH™ Mini Ostial System
Device Classification: Class II per 21 CFR §870.5100
Classification Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous
Product Code: LOX
Intended Use / Indications for Use:
The FLASH Flex™ Aorto-Ostial Angioplasty System is indicated for the post-delivery
expansion of balloon expandable stents within the coronary vasculature.
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K254022
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## Device Description:
The FLASH Flex™ Aorto-Ostial Angioplasty System (FLASH Flex™ System) is a family of rapid exchange (RX) dual balloon catheter systems that are available in multiple balloon diameter and length configurations. The catheters include a pressure relief feature that reduces the potential for over-pressurization of the Proximal Balloon. They are compatible with 0.014” (0.36 mm) guidewires and 6 Fr guide catheters. The FLASH Flex™ System includes a 20cc locking syringe for balloon inflation and deflation.
## Comparison with predicate device:
The FLASH Flex™ is an update to the currently cleared coronary FLASH catheters that implements design changes to improve certain aspects of the device. It is similar in design and identical in principle of operation to its predicate device, the FLASH™ Mini Ostial System. The differences in design between the subject and the predicate devices were made to enhance tip flexibility, catheter trackability, addition of Fluorosaver™ markers to reduce fluoro/radiation exposure, simplify the device’s preparation, and validate the use of ethylene oxide sterilization. Additionally, Verge™ Medical, Inc is seeking to narrow the indications for use of the subject device to solely focus use on, “post-delivery expansion of balloon expandable stents within the coronary vasculature.”
| Description | Subject Device | Predicate Device |
| --- | --- | --- |
| Device Name | FLASH Flex™ Aorto-Ostial Angioplasty System | FLASH™ Mini Ostial System |
| Manufacturer | Verge™ Medical, Inc. | Verge™ Medical, Inc. (formerly Ostial Corporation) |
| 510(k) # | K254022 | K152485 |
| Intended Use | Percutaneous Transluminal Coronary Angioplasty | Same |
| Indications for Use | The FLASH Flex™ Aorto-Ostial Angioplasty System is indicated for the post-delivery expansion of balloon expandable stents within the coronary vasculature. | The FLASH™ Mini Ostial System is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion.
The FLASH™ Mini Ostial System is also indicated for the post-delivery expansion of balloon expandable stents within the coronary vasculature. |
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K254022
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| Product Code | LOX | Same |
| --- | --- | --- |
| Regulation Name/Number | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter; 21 CFR 870.5100 | Same |
| Class | II | Same |
| Prescription/ Over-the-Counter | Prescription Only | Same |
| Single Use Only? | Yes | Same |
| Provided Sterile? | Yes | Same |
| Sterilization Method | Ethylene Oxide (EO) | E-beam |
| Packaged Components | Dual Balloon Catheter
20cc Syringe | Dual Balloon Catheter
10cc Syringe
1cc Syringe |
| Guidewire Compatibility | 0.014” (0.36 mm) | Same |
| Guide Catheter Compatibility | 6 Fr | Same |
| Catheter Sizes (balloon dia. x balloon length x working length) | 3.0mm x 8mm x 135cm
3.5mm x 8mm x 135cm
4.0mm x 8mm x 135cm
4.5mm x 8mm x 135cm
5.0mm x 12mm x 135cm | 3.0mm x 8mm x 135cm
3.5mm x 8mm x 135cm
4.0mm x 8mm x 135cm
4.5mm x 8mm x 135cm |
| Nominal Pressures | 3.0mm: 9 ATM
3.5mm: 9 ATM
4.0mm: 9 ATM
4.5mm: 9 ATM
5.0mm: 8 ATM | 3.0mm: 9 ATM
3.5mm: 9 ATM
4.0mm: 9 ATM
4.5mm: 9 ATM |
| Rated Balloon Pressures | 3.0mm: 16 ATM
3.5mm: 16 ATM
4.0mm: 16 ATM
4.5mm: 16 ATM
5.0mm: 12 ATM | 3.0mm: 20 ATM
3.5mm: 20 ATM
4.0mm: 20 ATM
4.5mm: 20 ATM |
| Materials | Medical-grade Nylon plastics, Pt/Ir, Stainless Steel, Polycarbonate, Silicone and Cyanoacrylate | Similar |
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K254022
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# Non-Clinical testing / Performance Data:
Non-clinical laboratory testing was performed on the FLASH Flex™ System to assure compliance with all pre-specified, clinically relevant acceptance criteria and to demonstrate substantial equivalence to the predicate device as it relates to their intended use. The following testing/assessments were performed:
- Visual and Dimensional Testing
- Tensile / Bond Strength Testing
- Torque Testing
- Burst Pressure Testing
- Balloon Fatigue Testing
- Drop Testing
- Package Testing
- Fluid Leak Testing
- Simulated Use Performance Testing
The performance bench tests demonstrated that the FLASH Flex™ System met all pre-defined acceptance criteria demonstrating that the subject device functions as intended and is substantially equivalent to the predicate device.
# Biocompatibility:
Testing was performed to assess biocompatibility of the FLASH Flex™ System’s patient-contacting components. The following tests were successfully performed:
- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemocompatibility
- Hemolysis (Direct)
- Thrombosis (PTT Assay)
- Thrombosis (SC5b-9 Elisa Assay)
- Thrombosis (Platelet and Leukocyte Measurement)
Adherence to the test methodologies and standards was maintained in all biocompatibility testing described. Each of the biocompatibility tests defined above passed pre-defined acceptance
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K254022
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criteria. There was no evidence of toxicity, sensitization, or irritation. Testing found samples to be non-hemolytic, non-activator, and non-pyrogenic. All testing was conducted in compliance with GLP regulations, 21 CFR Part 58.
## In-Vivo GLP Pre-Clinical Testing / Performance Data:
No animal studies were required to demonstrate substantial equivalence between the subject and predicate devices.
## Conclusion:
The Verge™ Medical, Inc. FLASH Flex™ System has similar intended use and the same or similar technological characteristics in its design, materials, and operating principles as the predicate device. Performance data demonstrates that the device functions as intended. The non-clinical performance tests demonstrate that the FLASH Flex™ System is substantially equivalent to the predicate device.
