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Infraredx, Inc.

Last updated May 27, 2026

What Infraredx, Inc. makes

Infraredx, Inc. manufactures single-use catheter and overtube balloon inflation devices, haemostasis valves, and intravascular ultrasound (IVUS) imaging catheters designed for cardiovascular procedures. Their portfolio includes imaging systems for intravascular and cardiovascular ultrasound, such as the TVC Imaging System™ and Dualpro™ IVUS+NIRS Imaging Catheter Kit, as well as disposable accessories like drapes and connector sets for medical equipment. These products are intended for use in diagnostic and interventional cardiology applications.

The company’s devices are classified under Class II regulatory categories in the US and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. Their products are intended for commercial distribution within the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Infraredx, Inc. manufacture?

Infraredx, Inc. specializes in devices primarily used in cardiovascular procedures. Their portfolio includes single-use catheter and overtube balloon inflation devices, haemostasis valves, and intravascular ultrasound (IVUS) imaging catheters. They also produce imaging systems like the TVC Imaging System™ and Dualpro™ IVUS+NIRS Imaging Catheter Kit, as well as disposable accessories such as medical equipment drapes and connector sets. These products are designed for diagnostic and interventional cardiology applications.

Where is Infraredx, Inc. based, and where are their devices intended for use?

Infraredx, Inc. is based in the United States. Their devices are intended for commercial distribution within the US market, as indicated by their regulatory listings and classification.

Which regulatory registries list devices manufactured by Infraredx, Inc.?

Devices from Infraredx, Inc. are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries track medical devices that have undergone the necessary regulatory processes to demonstrate safety and effectiveness for their intended use.

How are the devices manufactured by Infraredx, Inc. classified in the US?

The devices produced by Infraredx, Inc. fall under Class II regulatory classification in the US. Class II devices are those that pose moderate risk and require special controls to ensure their safety and effectiveness, which may include performance standards, post-market surveillance, or labeling requirements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: infraredx.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 888-680-7339
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 124065421

Catalogue (32)

Device	Model / Reference	Registries	Class	Status
GM-30 Inflation Device	GM-30NF	FDA UDI	Class II	Active
TVC Imaging System™	TVC-MC8	FDA UDI	Class II	Active
OKAY® II Y-Connector	YOK0B	FDA UDI	Class II	Active
TVC Imaging System™	TVC-MC9	FDA UDI	Class II	Active
GM-30 Accessory Kit	GLGMF-YOK0E	FDA UDI	Class II	Active
GM-30 Accessory Kit	GLGMF-YOK0A	FDA UDI	Class II	Active
TVC Insight™	TVC-C195-20	FDA UDI	Class II	Active
OKAY® II Y-Connector Set with Extension Tube	YOK0E	FDA UDI	Class II	Active
GM-30 Accessory Kit	GLGMN-YOK0E	FDA UDI	Class II	Active
Dualpro™ IVUS+NIRS Imaging Catheter Kit	TVC-C195-42	FDA UDI	Class II	Active
Makoto Integrated Intravascular Imaging System™	TVC-MC10i	FDA UDI	Class II	Active
TVC Insight™	TVC-C195-22	FDA UDI	Class II	Active
TVC Integrated Imaging System™	TVC-MC9i	FDA UDI	Class II	Active
GM-30 Inflation Device	GM-30N	FDA UDI	Class II	Active
TVC Imaging System™	TVC-MC8	FDA UDI	Class II	Active
Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit	TVC-E195-42	FDA UDI	Class II	Active
OKAY® II Y-Connector Set	YOK0A	FDA UDI	Class II	Active
TVC Insight XB™	TVC-C195-32	FDA UDI	Class II	Active
TVC Controller Sterile Barrier	TVC-MC8-B1	FDA UDI	Class II	Active
GM-30 Inflation Device	GM-30NL	FDA UDI	Class II	Active
GM-30 Accessory Kit	GLGMN-YOK0A	FDA UDI	Class II	Active
Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )	K241576	FDA 510(k)	Class II	Active
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter , TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42	K213303	FDA 510(k)	Class II	Active
Tvc Imaging System, Tvc Insight Catheter	K141682	FDA 510(k)	Class II	Active
Infraredix Nir Imaging System, Gen. 1.0, Model Mc-5	K072932	FDA 510(k)	Class II	Active
Intraredx Nir Imaging System, Model Mc-5	K052908	FDA 510(k)	Class II	Active
Tvc Imaging System, Tvc Insight Catheter	K130719	FDA 510(k)	Class II	Active
TVC Imaging System, TVC Catheter	K163345	FDA 510(k)	Class II	Active
Tvc Imaging System Model Nirs-Mc7-70	K123108	FDA 510(k)	Class II	Active
Tvc Imaging System, Tvc Insight Catheter	K133897	FDA 510(k)	Class II	Active
Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter	K183599	FDA 510(k)	Class II	Active
Lipiscan Ivus Imaging System Model Nirs-Mc7-70	K093993	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Infraredx, Inc. has one FDA recall record initiated on December 15, 2016, which is recorded as terminated. The recall pertains to the TVC Imaging System (TVC-MC9), where near-infrared spectroscopic images (Chemograms) in some cases exhibited an unusual horizontal orientation of yellow, indicating potential variations in lipid core plaque visualization.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Dec 15, 2016	Z-0940-2017	—	terminated	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 (indicating the presence of lipid core plaques) was horizontally-oriented