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Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit

FDA UDI

Class II (US FDA UDI)

by Infraredx, Inc.

Identity

Trade Name
Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit FDA UDI
Generic Name
Intravascular ultrasound imaging catheter, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
TVC-E195-42 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
TVC-E195-42 FDA UDI
Primary DI / UDI-DI
00857595006180 FDA UDI
FDA Product Code
OGZ FDA UDI
IYO FDA UDI
GMDN Term
Intravascular ultrasound imaging catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
892.1560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intravascular ultrasound imaging catheter, single-use

Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit by Infraredx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular ultrasound imaging catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Infraredx, Inc.

Sources (1)

  • FDA UDI 7ae642c3-914f-4de7-867e-2438cf01edb2 36 fields · synced May 31, 2026