BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE— 510(k) K931464

Name: FDA 510(k) clearance K931464
Creator: U.S. Food and Drug Administration
Published: 1993-10-18

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K931464 for BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE, Substantially Equivalent on 1993-10-18. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-03-24
Decision date: 1993-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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