PTFE RINGED GORE-TEX VASCULAR GRAFT— 510(k) K991683

Name: FDA 510(k) clearance K991683
Creator: U.S. Food and Drug Administration
Published: 1999-09-08

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K991683 for PTFE RINGED GORE-TEX VASCULAR GRAFT, Substantially Equivalent on 1999-09-08. 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: 1999-05-17
Decision date: 1999-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

Download summary PDF View on FDA.gov ↗

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