GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)— 510(k) K964061

Name: FDA 510(k) clearance K964061
Creator: U.S. Food and Drug Administration
Published: 1997-02-20

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K964061 for GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD), Substantially Equivalent on 1997-02-20. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1996-10-10
Decision date: 1997-02-20
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.