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FDA 510(k)

ATRIUM PLASMA TFE SYNTHETIC ARTERY

K-Number: K853725 · 1985-12-09

ApplicantAtrium Medical Corp.
Decision Date1985-12-09
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATRIUM PLASMA TFE SYNTHETIC ARTERY 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 1985-12-09 under 510(k) number K853725. 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 PLASMA TFE SYNTHETIC ARTERY?

ATRIUM PLASMA TFE SYNTHETIC ARTERY is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is Atrium Medical Corp.. The 510(k) number is K853725.

When did ATRIUM PLASMA TFE SYNTHETIC ARTERY receive FDA 510(k) clearance?

ATRIUM PLASMA TFE SYNTHETIC ARTERY received FDA 510(k) clearance on 1985-12-09, under 510(k) number K853725.

Who is the listed applicant for ATRIUM PLASMA TFE SYNTHETIC ARTERY?

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 PLASMA TFE SYNTHETIC ARTERY?

The FDA product code for ATRIUM PLASMA TFE SYNTHETIC ARTERY is DSY.

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Other records listing Atrium Medical Corp. as applicant

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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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