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TVC Imaging System, TVC Insight Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130719

by Infraredx, Inc.

Identifiers

510(k) Number
K130719 FDA 510(k)
FDA Product Code
OGZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1200 FDA 510(k)
Regulation Number
870.1200 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TVC Imaging System, TVC Insight Catheter is a Combination NIRS/IVUS Imaging System (Near-Infrared Spectroscopy and Intravascular Ultrasound) designed for intravascular examination of coronary arteries. It integrates spectroscopic lipid detection with structural imaging to assess plaque morphology during invasive coronary angiography. The device operates by deploying the TVC Insight Catheter, which simultaneously acquires NIRS and IVUS data for comprehensive vascular analysis.

This system is supplied as a cart-based console with integrated imaging capabilities, paired with the TVC Insight Catheter for intravascular access. It is intended for single-use in controlled clinical settings, such as cardiac catheterization labs, and requires compliance with FDA 510(k) clearance (K130719). The device is classified under Device Class II (FDA regulation 870.1200) and is regulated under the Cardiovascular medical specialty. No sterility or MRI safety specifications are noted in the available data.

Frequently asked questions

What is the TVC Insight Catheter used for?

The TVC Insight Catheter is designed for intravascular examination of coronary arteries, integrating Near-Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) imaging. This combination allows clinicians to simultaneously assess plaque morphology and detect lipid content within the arterial walls during invasive coronary angiography, providing comprehensive vascular analysis.

How is the TVC Imaging System supplied?

The TVC Imaging System is supplied as a cart-based console with integrated imaging capabilities, paired with the TVC Insight Catheter. The console houses the imaging technology, while the catheter is inserted intravascularly to acquire NIRS and IVUS data. This setup is intended for use in controlled clinical environments like cardiac catheterization labs.

Is the TVC Insight Catheter single-use or reusable?

The TVC Insight Catheter is intended for single-use only. This design ensures patient safety and reduces the risk of cross-contamination between procedures, aligning with best practices for medical devices used in invasive procedures.

What regulatory clearance does the TVC Imaging System have?

The TVC Imaging System holds FDA 510(k) clearance under the reference number K130719. It is classified under Device Class II (FDA regulation 870.1200) and is regulated under the Cardiovascular medical specialty. The clearance confirms that the device is substantially equivalent to a predicate device.

Where can the TVC Imaging System be used?

The TVC Imaging System is intended for use in controlled clinical settings such as cardiac catheterization labs. Its design and regulatory clearance make it suitable for invasive coronary angiography procedures where detailed vascular imaging is required.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Infraredx, Inc. TVC-MC9 TVC Imaging System™ - RevMed, TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K133897) — FDA 510 (k ..., TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K130719) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Infraredx, Inc.

Sources (1)

  • FDA 510(k) K130719 24 fields · synced Oct 1, 2026