DISPOSABLE STEERABLE ANGIOSCOPE— 510(k) K931421

Name: FDA 510(k) clearance K931421
Creator: U.S. Food and Drug Administration
Published: 1993-06-16

Substantially Equivalent

Endovascular, Inc.

FDA 510(k) clearance K931421 for DISPOSABLE STEERABLE ANGIOSCOPE, Substantially Equivalent on 1993-06-16. Applicant: Endovascular, Inc.. Device class: 2.

Clearance details

Applicant: Endovascular, Inc.
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-03-22
Decision date: 1993-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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