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FDA 510(k)

BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS

K-Number: K944858 · 1995-01-05

ApplicantBaxter Edwards
Decision Date1995-01-05
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Edwards. It received FDA 510(k) clearance on 1995-01-05 under 510(k) number K944858. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS?

BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS is a medical device that received FDA 510(k) clearance on 1995-01-05. The listed applicant is Baxter Edwards. The 510(k) number is K944858.

When did BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS receive FDA 510(k) clearance?

BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS received FDA 510(k) clearance on 1995-01-05, under 510(k) number K944858.

Who is the listed applicant for BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS?

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

What is the FDA product code for BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS?

The FDA product code for BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS is DSY.

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Other records listing Baxter Edwards as applicant

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.

K993816BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FDK981909BAXTER HEMOSTASIS VALVE INTRODUCERSK980487CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSMK965137FOGARTY VALVULOTOME MODEL 700091K964021INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER

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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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