GORE-TEX VASCULAR GRAFT— 510(k) K881732

Name: FDA 510(k) clearance K881732
Creator: U.S. Food and Drug Administration
Published: 1988-05-18

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K881732 for GORE-TEX VASCULAR GRAFT, Substantially Equivalent on 1988-05-18. 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: 1988-04-22
Decision date: 1988-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.