TVC IMAGING SYSTEM, TVC INSIGHT CATHETER— 510(k) K130719

Substantially Equivalent

Infraredx, Inc.

FDA 510(k) clearance K130719 for TVC IMAGING SYSTEM, TVC INSIGHT CATHETER, Substantially Equivalent on 2013-10-17. Applicant: Infraredx, Inc..

Clearance details

Applicant: Infraredx, Inc.
Product code: Code OGZ
Advisory panel: Cardiovascular
Date received: 2013-03-18
Decision date: 2013-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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