TVC Imaging System, TVC Catheter— 510(k) K163345

Substantially Equivalent

Infraredx, Inc.

FDA 510(k) clearance K163345 for TVC Imaging System, TVC Catheter, Substantially Equivalent on 2017-06-21. Applicant: Infraredx, Inc..

Clearance details

Applicant: Infraredx, Inc.
Product code: Code OGZ
Advisory panel: Cardiovascular
Date received: 2016-11-29
Decision date: 2017-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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