FEP-RINGED GORE-TEX@ VASCULAR GRAFT— 510(k) K821826

Name: FDA 510(k) clearance K821826
Creator: U.S. Food and Drug Administration
Published: 1982-12-29

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K821826 for FEP-RINGED GORE-TEX@ VASCULAR GRAFT, Substantially Equivalent on 1982-12-29. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DYF
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1982-06-22
Decision date: 1982-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYF

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K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS2001-05-14
K000504 — ADVANTA SUPER SOFT GRAFT2000-03-01
K992958 — ADVANTA GRAFT (<6MM)1999-10-01
K991683 — PTFE RINGED GORE-TEX VASCULAR GRAFT1999-09-08
K992441 — ADVANTA GRAFT1999-08-20

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K233551 — GORE® ACUSEAL Vascular Graft2023-12-19
K231505 — GORE® ACUSEAL Vascular Graft2023-06-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.