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FDA 510(k)

Advanta VXT Vascular Graft, Flixene Vascular Graft

K-Number: K231972 · 2024-03-28

ApplicantAtrium Medical Corporation
Decision Date2024-03-28
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Advanta VXT Vascular Graft, Flixene Vascular Graft is a medical device manufactured by Atrium Medical Corporation. It received FDA 510(k) clearance on 2024-03-28 under approval number K231972. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advanta VXT Vascular Graft, Flixene Vascular Graft?

Advanta VXT Vascular Graft, Flixene Vascular Graft is a medical device that received FDA 510(k) clearance on 2024-03-28. It is manufactured by Atrium Medical Corporation. The 510(k) number is K231972.

When was Advanta VXT Vascular Graft, Flixene Vascular Graft approved by the FDA?

Advanta VXT Vascular Graft, Flixene Vascular Graft received FDA 510(k) clearance on 2024-03-28, under approval number K231972.

What company makes Advanta VXT Vascular Graft, Flixene Vascular Graft?

Advanta VXT Vascular Graft, Flixene Vascular Graft is manufactured by Atrium Medical Corporation.

What is the FDA product code for Advanta VXT Vascular Graft, Flixene Vascular Graft?

The FDA product code for Advanta VXT Vascular Graft, Flixene Vascular Graft is DSY.

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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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