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Infraredx, Inc.

11 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) (K241576)Infraredx, Inc.2025-02-26
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 (K213303)Infraredx, Inc.2021-12-07
Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (K183599)Infraredx, Inc.2019-04-12
TVC Imaging System, TVC Catheter (K163345)Infraredx, Inc.2017-06-21
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K141682)Infraredx, Inc.2014-11-24
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K133897)Infraredx, Inc.2014-04-23
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K130719)Infraredx, Inc.2013-10-17
TVC IMAGING SYSTEM MODEL NIRS-MC7-70 (K123108)Infraredx, Inc.2013-03-15
LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 (K093993)Infraredx, Inc.2010-06-30
INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 (K072932)Infraredx, Inc.2008-04-25
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 (K052908)Infraredx, Inc.2006-06-23

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Every clearance here is in the API, with alerts when new ones post.