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FDA 510(k)

FLIXENE IFG VASCULAR GRAFT

K-Number: K130142 · 2013-03-15

ApplicantAtrium Medical Corporation
Decision Date2013-03-15
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLIXENE IFG VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corporation. It received FDA 510(k) clearance on 2013-03-15 under 510(k) number K130142. 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 FLIXENE IFG VASCULAR GRAFT?

FLIXENE IFG VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 2013-03-15. The listed applicant is Atrium Medical Corporation. The 510(k) number is K130142.

When did FLIXENE IFG VASCULAR GRAFT receive FDA 510(k) clearance?

FLIXENE IFG VASCULAR GRAFT received FDA 510(k) clearance on 2013-03-15, under 510(k) number K130142.

Who is the listed applicant for FLIXENE IFG VASCULAR GRAFT?

The FDA 510(k) record lists Atrium Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLIXENE IFG VASCULAR GRAFT?

The FDA product code for FLIXENE IFG VASCULAR GRAFT is DSY.

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Other records listing Atrium Medical Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231972Advanta VXT Vascular Graft, Flixene Vascular GraftK201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest DrainK110110ATRIUM CENTRILFX MESH

Related Devices (Code: DSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.

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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