TRANSLUMINAL ENDARTERECTOMY DEVICE— 510(k) K884154

Name: FDA 510(k) clearance K884154
Creator: U.S. Food and Drug Administration
Published: 1988-12-27

Substantially Equivalent

Thomas J. Fogarty, M.D.

FDA 510(k) clearance K884154 for TRANSLUMINAL ENDARTERECTOMY DEVICE, Substantially Equivalent on 1988-12-27. Applicant: Thomas J. Fogarty, M.D.. Device class: 2.

Clearance details

Applicant: Thomas J. Fogarty, M.D.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1988-10-03
Decision date: 1988-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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