Occlusion Perfusion Catheter— 510(k) K153488

Name: FDA 510(k) clearance K153488
Creator: U.S. Food and Drug Administration
Published: 2016-02-25

Substantially Equivalent

Advanced Catheter Therapies, Inc.

FDA 510(k) clearance K153488 for Occlusion Perfusion Catheter, Substantially Equivalent on 2016-02-25. Applicant: Advanced Catheter Therapies, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Catheter Therapies, Inc.
Product code: Code QEY
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2015-12-04
Decision date: 2016-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chattanooga, TN, US

Download summary PDF View on FDA.gov ↗

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