GORE-TEX VASCULAR GRAFT, FEP-RINGED— 510(k) K842144

Name: FDA 510(k) clearance K842144
Creator: U.S. Food and Drug Administration
Published: 1984-10-01

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K842144 for GORE-TEX VASCULAR GRAFT, FEP-RINGED, Substantially Equivalent on 1984-10-01. 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: 1984-05-30
Decision date: 1984-10-01
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
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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.