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FDA 510(k)

ADVANTA T-GRAFT

K-Number: K051332 · 2005-09-29

ApplicantAtrium Medical Corp.
Decision Date2005-09-29
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADVANTA T-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 2005-09-29 under 510(k) number K051332. 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 T-GRAFT?

ADVANTA T-GRAFT is a medical device that received FDA 510(k) clearance on 2005-09-29. The listed applicant is Atrium Medical Corp.. The 510(k) number is K051332.

When did ADVANTA T-GRAFT receive FDA 510(k) clearance?

ADVANTA T-GRAFT received FDA 510(k) clearance on 2005-09-29, under 510(k) number K051332.

Who is the listed applicant for ADVANTA T-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 ADVANTA T-GRAFT?

The FDA product code for ADVANTA T-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 CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912

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Related Devices (Code: DSY)

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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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