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Catheter, Intravascular, Plaque Morphology Evaluation

FDA product code OGZ · Class 2 · Cardiovascular

15

Registered devices

24

Adverse events

1

Recalls

9

510(k) clearances

Devices with this code

TVC Integrated Imaging System™ — Nipro Vascular Innovations Americas, Inc.Makoto Intravascular Imaging System™ — Nipro Vascular Innovations Americas, Inc.TVC Insight XB™ — Nipro Vascular Innovations Americas, Inc.HyperVue Imaging System — Spectrawave, Inc.TVC Controller Sterile Barrier — Nipro Vascular Innovations Americas, Inc.TVC Imaging System™ — Nipro Vascular Innovations Americas, Inc.Dualpro™ IVUS+NIRS Imaging Catheter Kit — Nipro Vascular Innovations Americas, Inc.TVC Imaging System™ — Nipro Vascular Innovations Americas, Inc.Dualpro™ IVUS+NIRS Imaging Catheter Kit — Nipro Vascular Innovations Americas, Inc.TVC Imaging System™ — Nipro Vascular Innovations Americas, Inc.TVC Insight™ — Nipro Vascular Innovations Americas, Inc.TVC Insight™ — Nipro Vascular Innovations Americas, Inc.Makoto Integrated Intravascular Imaging System™ — Nipro Vascular Innovations Americas, Inc.Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit — Nipro Vascular Innovations Americas, Inc.Starlight Imaging Catheter — Spectrawave, Inc.

Recent 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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.