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FDA 510(k)

UNI-GRAFT K DV VASCULAR GRAFT

K-Number: K991813 · 1999-06-01

ApplicantAtrium Medical Corp.
Decision Date1999-06-01
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNI-GRAFT K DV 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 1999-06-01 under 510(k) number K991813. 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 UNI-GRAFT K DV VASCULAR GRAFT?

UNI-GRAFT K DV VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 1999-06-01. The listed applicant is Atrium Medical Corp.. The 510(k) number is K991813.

When did UNI-GRAFT K DV VASCULAR GRAFT receive FDA 510(k) clearance?

UNI-GRAFT K DV VASCULAR GRAFT received FDA 510(k) clearance on 1999-06-01, under 510(k) number K991813.

Who is the listed applicant for UNI-GRAFT K DV 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 UNI-GRAFT K DV VASCULAR GRAFT?

The FDA product code for UNI-GRAFT K DV VASCULAR GRAFT 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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