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FDA 510(k)

ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT

K-Number: K102596 · 2010-10-05

ApplicantAtrium Medical Corp.
Decision Date2010-10-05
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATRIUM GRADUATED WALL FLIXENE AX-BIFEM 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 2010-10-05 under 510(k) number K102596. 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 GRADUATED WALL FLIXENE AX-BIFEM GRAFT?

ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT is a medical device that received FDA 510(k) clearance on 2010-10-05. The listed applicant is Atrium Medical Corp.. The 510(k) number is K102596.

When did ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT receive FDA 510(k) clearance?

ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT received FDA 510(k) clearance on 2010-10-05, under 510(k) number K102596.

Who is the listed applicant for ATRIUM GRADUATED WALL FLIXENE AX-BIFEM 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 GRADUATED WALL FLIXENE AX-BIFEM GRAFT?

The FDA product code for ATRIUM GRADUATED WALL FLIXENE AX-BIFEM 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 SYSTEMK122138ATRIUM FLIXENE IFG VASCULAR GRAFTK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK093431CLEARWAY 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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