AMIGO REMOTE CATHETER SYSTEM— 510(k) DEN140009

Unknown

Catheter Robotics, Inc.

FDA 510(k) clearance DEN140009 for AMIGO REMOTE CATHETER SYSTEM, Unknown on 2014-12-18. Applicant: Catheter Robotics, Inc.. Device class: 2.

Clearance details

Applicant: Catheter Robotics, Inc.
Product code: Code PJB
Device class: Class 2
Regulation: 21 CFR 870.5700
Advisory panel: Cardiovascular
Date received: 2014-02-18
Decision date: 2014-12-18
Decision: Unknown
Clearance type: Direct
Location: Mt. Olive, NJ, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.