Data / Medical devices / United States / Verge Medical Inc.
Verge Medical Inc.: FDA-registered device maker in Campbell, CA, United States, 9 510(k) clearances
Verge Medical Inc. is registered with the FDA (registration 3008700817) in Campbell, CA, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated April 2, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008700817
- Address
- 747 Camden Ave Ste A, Campbell, CA, United States, 95008
- Owner or operator
- Verge Medical Inc. (10034123)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- July 26, 2012
- Registered through
- 2026
- Brand names listed
- FLASH Flex Aorto-Ostial Angioplasty System, FLASH MINI Ostial System, FLASH Ostial System, FLASH Ostial System OTW, Ostial Corporation/Verge Medical Inc./FLASH MINI Ostial System, Ostial Corporation/Verge Medical Inc./FLASH Ostial System, Ostial Corporation/Verge Medical Inc./FLASH Ostial System OTW, Ostial Corporation/Verge Medical Inc./Flash Ostial System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2026 | K254022 | FLASH Flex Aorto-Ostial Angioplasty System | LOX | Substantially Equivalent | Verge Medical, Inc. | accessdata.fda.gov |
| January 21, 2026 | K253730 | RoVo Mechanical Thrombectomy System | QEW | Substantially Equivalent | Verge Medical, Inc. | accessdata.fda.gov |
| February 16, 2016 | K152485 | FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm | LOX | Substantially Equivalent | Ostial Corporation | accessdata.fda.gov |
| May 8, 2015 | K150946 | FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm | LIT | Substantially Equivalent | Ostial Corporation | accessdata.fda.gov |
| August 6, 2013 | K131450 | FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 | LOX | Substantially Equivalent | Ostial Corporation | accessdata.fda.gov |
| October 11, 2012 | K122178 | FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 | LOX | Substantially Equivalent | Ostial Corporation | accessdata.fda.gov |
| September 5, 2012 | K122379 | FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM | LIT | Substantially Equivalent | Ostial Corporation | accessdata.fda.gov |
| June 29, 2012 | K113775 | FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM | LOX | Substantially Equivalent | Ostial Corporation | accessdata.fda.gov |
| March 29, 2012 | K120738 | FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM | LIT | Substantially Equivalent | Ostial Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 14, 2021 | 88334 | Class II | Terminated | FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA | Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
Updated April 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.