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FDA 510(k)

FEP-RINGED GORE-TEX@ VASCULAR GRAFT

K-Number: K821826 · 1982-12-29

ApplicantW. L. Gore & Associates, Inc.
Decision Date1982-12-29
Product CodeDYF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FEP-RINGED GORE-TEX@ VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 1982-12-29 under 510(k) number K821826. The device is classified under product code DYF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEP-RINGED GORE-TEX@ VASCULAR GRAFT?

FEP-RINGED GORE-TEX@ VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 1982-12-29. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K821826.

When did FEP-RINGED GORE-TEX@ VASCULAR GRAFT receive FDA 510(k) clearance?

FEP-RINGED GORE-TEX@ VASCULAR GRAFT received FDA 510(k) clearance on 1982-12-29, under 510(k) number K821826.

Who is the listed applicant for FEP-RINGED GORE-TEX@ VASCULAR GRAFT?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEP-RINGED GORE-TEX@ VASCULAR GRAFT?

The FDA product code for FEP-RINGED GORE-TEX@ VASCULAR GRAFT is DYF.

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Other records listing W. L. Gore & Associates, Inc. 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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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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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