PRECLUDE IMA SLEEVE— 510(k) K960532

Name: FDA 510(k) clearance K960532
Creator: U.S. Food and Drug Administration
Published: 1996-05-23

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K960532 for PRECLUDE IMA SLEEVE, Substantially Equivalent on 1996-05-23. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code MFX
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 1996-02-07
Decision date: 1996-05-23
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.