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FDA 510(k)

BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT

K-Number: K944844 · 1995-03-31

ApplicantBaxter Healthcare Corp
Decision Date1995-03-31
Product CodeDYF
Advisory CommitteeCV
DecisionUnknown

Device Summary

BAXTER REINFORCED EXPANDED PTFE STEPPED 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 1995-03-31 under 510(k) number K944844. The device is classified under product code DYF. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT?

BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 1995-03-31. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K944844.

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

BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT received FDA 510(k) clearance on 1995-03-31, under 510(k) number K944844.

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

The FDA product code for BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT is DYF.

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Related Devices (Code: DYF)

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.

K004012IMPRA CARBOFLO EPTFE VASCULAR GRAFTSImpra, Inc.K000504ADVANTA SUPER SOFT GRAFTAtrium Medical Corp.K992958ADVANTA GRAFT (<6MM)Atrium Medical Corp.K991683PTFE RINGED GORE-TEX VASCULAR GRAFTW. L. Gore & Associates, Inc.K992441ADVANTA GRAFTAtrium Medical Corp.K984183PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451Possis Medical, 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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