INTRAVASCULAR IMAGING SYSTEM— 510(k) K895159

Name: FDA 510(k) clearance K895159
Creator: U.S. Food and Drug Administration
Published: 1990-03-12

Substantially Equivalent

Intertherapy, Inc.

FDA 510(k) clearance K895159 for INTRAVASCULAR IMAGING SYSTEM, Substantially Equivalent on 1990-03-12. Applicant: Intertherapy, Inc.. Device class: 2.

Clearance details

Applicant: Intertherapy, Inc.
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1989-08-23
Decision date: 1990-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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