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FDA 510(k)

EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS

K-Number: K910864 · 1991-04-01

ApplicantVascutek, Ltd.
Decision Date1991-04-01
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 1991-04-01 under 510(k) number K910864. 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 EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS?

EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS is a medical device that received FDA 510(k) clearance on 1991-04-01. The listed applicant is Vascutek, Ltd.. The 510(k) number is K910864.

When did EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS receive FDA 510(k) clearance?

EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS received FDA 510(k) clearance on 1991-04-01, under 510(k) number K910864.

Who is the listed applicant for EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS?

The FDA 510(k) record lists Vascutek, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS?

The FDA product code for EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS is DSY.

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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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