FLASH Flex Aorto-Ostial Angioplasty System— 510(k) K254022
Substantially EquivalentVerge Medical, Inc.
FDA 510(k) clearance K254022 for FLASH Flex Aorto-Ostial Angioplasty System, Substantially Equivalent on 2026-04-02. Applicant: Verge Medical, Inc.. Device class: 2.
Summary
Verge Medical's FLASH Flex Aorto-Ostial Angioplasty System is filed under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous).
Class II, 21 CFR 870.5100. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Verge Medical filed from Campbell, California. The decision came 107 calendar days after FDA received it (December 16, 2025 to April 2, 2026).
Clearance details
- Applicant
- Verge Medical, Inc.
- Product code
- Product code LOX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Campbell, CA, US
Recent devices under product code LOX
view allMore clearances from Verge Medical, Inc.
view allAdverse events under product code LOX
product code LOX- Death
- 190
- Injury
- 1,498
- Malfunction
- 9,670
- Total
- 11,358
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.