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FDA 510(k)

BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT

K-Number: K933590 · 1994-01-26

ApplicantBaxter Healthcare Corp
Decision Date1994-01-26
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1994-01-26 under 510(k) number K933590. 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 BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT?

BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K933590.

When did BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT receive FDA 510(k) clearance?

BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT received FDA 510(k) clearance on 1994-01-26, under 510(k) number K933590.

Who is the listed applicant for BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT?

The FDA product code for BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT 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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