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FDA 510(k)

ATRIUM FLIXENE IFG VASCULAR GRAFT

K-Number: K122138 · 2012-08-17

ApplicantAtrium Medical Corp.
Decision Date2012-08-17
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATRIUM FLIXENE IFG VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 2012-08-17 under 510(k) number K122138. 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 ATRIUM FLIXENE IFG VASCULAR GRAFT?

ATRIUM FLIXENE IFG VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 2012-08-17. The listed applicant is Atrium Medical Corp.. The 510(k) number is K122138.

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

ATRIUM FLIXENE IFG VASCULAR GRAFT received FDA 510(k) clearance on 2012-08-17, under 510(k) number K122138.

Who is the listed applicant for ATRIUM FLIXENE IFG VASCULAR GRAFT?

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

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

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

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Other records listing Atrium Medical Corp. 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.

K130131EDRAIN CHEST DRAINAGE SYSTEMK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912K100076ATRIUM C-QUR OVT MESH

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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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