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FDA 510(k)

DEBAKEY VASCULOUR-D PROSTHESES

K-Number: K770235 · 1977-02-24

ApplicantUsci, Div. C.R. Bard, Inc.
Decision Date1977-02-24
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEBAKEY VASCULOUR-D PROSTHESES is the device name listed in this FDA 510(k) record. The listed applicant is Usci, Div. C.R. Bard, Inc.. It received FDA 510(k) clearance on 1977-02-24 under 510(k) number K770235. 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 DEBAKEY VASCULOUR-D PROSTHESES?

DEBAKEY VASCULOUR-D PROSTHESES is a medical device that received FDA 510(k) clearance on 1977-02-24. The listed applicant is Usci, Div. C.R. Bard, Inc.. The 510(k) number is K770235.

When did DEBAKEY VASCULOUR-D PROSTHESES receive FDA 510(k) clearance?

DEBAKEY VASCULOUR-D PROSTHESES received FDA 510(k) clearance on 1977-02-24, under 510(k) number K770235.

Who is the listed applicant for DEBAKEY VASCULOUR-D PROSTHESES?

The FDA 510(k) record lists Usci, Div. C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEBAKEY VASCULOUR-D PROSTHESES?

The FDA product code for DEBAKEY VASCULOUR-D PROSTHESES is DSY.

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Other records listing Usci, Div. C.R. Bard, Inc. as applicant

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K940092USCI INPUT INTRODUCER SETK884209USCI DORROS INFUSION/PROBING CATHETERK771823CATHETER, CARDIOVASCULARK772021TRC STAINLESS STEEL SAFETY SPRING GUIDESK771982888 ARTERIAL/VENOUS CATHETER INTRODUCERK770835PATCH FABRIC

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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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