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FDA 510(k)

FLASH Flex™ Aorto-Ostial Angioplasty System

K-Number: K254022 · 2026-04-02

ApplicantVerge Medical, Inc.
Decision Date2026-04-02
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLASH Flex™ Aorto-Ostial Angioplasty System is a medical device manufactured by Verge Medical, Inc.. It received FDA 510(k) clearance on 2026-04-02 under approval number K254022. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLASH Flex™ Aorto-Ostial Angioplasty System?

FLASH Flex™ Aorto-Ostial Angioplasty System is a medical device that received FDA 510(k) clearance on 2026-04-02. It is manufactured by Verge Medical, Inc.. The 510(k) number is K254022.

When was FLASH Flex™ Aorto-Ostial Angioplasty System approved by the FDA?

FLASH Flex™ Aorto-Ostial Angioplasty System received FDA 510(k) clearance on 2026-04-02, under approval number K254022.

What company makes FLASH Flex™ Aorto-Ostial Angioplasty System?

FLASH Flex™ Aorto-Ostial Angioplasty System is manufactured by Verge Medical, Inc..

What is the FDA product code for FLASH Flex™ Aorto-Ostial Angioplasty System?

The FDA product code for FLASH Flex™ Aorto-Ostial Angioplasty System is LOX.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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