AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES— 510(k) K113628

Name: FDA 510(k) clearance K113628
Creator: U.S. Food and Drug Administration
Published: 2012-06-12

Substantially Equivalent

Catheter Robotics, Inc.

FDA 510(k) clearance K113628 for AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES, Substantially Equivalent on 2012-06-12. Applicant: Catheter Robotics, Inc.. Device class: 2.

Clearance details

Applicant: Catheter Robotics, Inc.
Product code: Code DXX
Device class: Class 2
Regulation: 21 CFR 870.1290
Advisory panel: Cardiovascular
Date received: 2011-12-08
Decision date: 2012-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Olive, NJ, 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.