CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600— 510(k) K911384

Name: FDA 510(k) clearance K911384
Creator: U.S. Food and Drug Administration
Published: 1991-06-25

Substantially Equivalent

Endosonics Corp.

FDA 510(k) clearance K911384 for CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600, Substantially Equivalent on 1991-06-25. Applicant: Endosonics Corp.. Device class: 2.

Clearance details

Applicant: Endosonics Corp.
Product code: Code DXK
Device class: Class 2
Regulation: 21 CFR 870.2330
Advisory panel: Cardiovascular
Date received: 1991-03-28
Decision date: 1991-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cordova, CA, 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.