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Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit

Nipro Vascular Innovations Americas, Inc. · Model TVC-E195-42 · UDI-DI 00857595006180

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Description

The Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit (TVC-E195-42) is a single use, disposable coronary and peripheral imaging catheter and accessory kit designed for use only with the Makoto Intravascular Imaging System™ (TVC-MC10 and TVC-MC10i). The high definition intravascular ultrasound imaging catheter combines 50 MHz Extended Bandwidth IVUS transducer for acquisition of vessel structure. The Infraredx Clarispro™ HD-IVUS Imaging Catheter features a durable hydrophilic coating for improved deliverability. Indications for Use: 1. The Makoto Intravascular Imaging System™ is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. b. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.

Recalls

Date	Firm	Reason
2016-12-15	Infraredx, Inc.	Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demonstrated an unusual appearance in that the yellow in the image (indicati

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.