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CVIS Insight Imaging Catheter for Intraluminal Use

FDA 510(k)

Class II (US FDA 510(k))

510(k) K921147

by Cardiovascular Imaging Systems, Inc.

Identifiers

510(k) Number
K921147 FDA 510(k)
FDA Product Code
ITX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1570 FDA 510(k)
Regulation Number
892.1570 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CVIS Insight Imaging Catheter for Intraluminal Use is a diagnostic ultrasonic transducer designed for intravascular imaging. Classified under product code ITX as a Transducer, Ultrasonic, Diagnostic, it generates real-time ultrasound images of blood vessels and cardiac structures. This device aids in visualizing the lumen and walls of coronary and peripheral arteries, facilitating assessment of vascular anatomy and pathology. Its primary function aligns with intravascular ultrasound (IVUS) applications, enabling clinicians to evaluate plaque burden, vessel dimensions, and stent placement accuracy.

This catheter is intended for single-use in clinical settings such as cardiac catheterization labs and interventional radiology suites. Supplied sterile and packaged for one-time use, it requires no special storage conditions beyond standard medical device handling. The device is regulated under FDA 510(k) clearance (K921147) and falls under Class II with Special Controls, adhering to radiology advisory committee review. No MRI safety information or reusable specifications are indicated in the regulatory data.

Frequently asked questions

What is the CVIS Insight Imaging Catheter used for?

The CVIS Insight Imaging Catheter is designed for intravascular ultrasound (IVUS) imaging, allowing clinicians to visualize the lumen and walls of coronary and peripheral arteries in real time. This helps evaluate vascular anatomy, identify plaque burden, measure vessel dimensions, and verify stent placement accuracy during procedures like cardiac catheterization or interventional radiology.

Is the CVIS Insight Imaging Catheter intended for single-use or reuse?

This catheter is explicitly intended for single-use only. It is supplied sterile and packaged for one-time clinical use, ensuring patient safety and compliance with medical device standards. Reuse is not recommended or supported by the manufacturer.

What storage conditions are required for the CVIS Insight Imaging Catheter?

The device does not require special storage conditions beyond standard medical device handling. It is supplied sterile and packaged for single-use, so it should be stored in a clean, dry environment protected from contamination until use.

Does the CVIS Insight Imaging Catheter have any MRI safety information?

The regulatory data for this device does not include any specific MRI safety information. Clinicians should follow standard safety protocols for intravascular devices when using this catheter near MRI equipment, ensuring compatibility and patient safety.

What regulatory pathway does the CVIS Insight Imaging Catheter follow?

The CVIS Insight Imaging Catheter is regulated under the FDA 510(k) clearance process (K921147) and is classified as a Class II device with Special Controls. It was reviewed by the Radiology Advisory Committee (RA) and determined to be substantially equivalent to a predicate device. This pathway ensures compliance with radiology-specific standards.

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: Cvis Insight Imaging Catheter for Intraluminal, K921631 - Cvis Insight Imaging Catheter for Intra..., CVIS INSIGHT IMAGING CATHETER (K901562) — FDA 510(k) | Innolitics, K904618 FDA 510 (k) - CVIS INSIGHT IMAGING CATHETER

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardiovascular Imaging Systems, Inc.

Sources (1)

  • FDA 510(k) K921147 24 fields · synced Oct 1, 2026