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CVIS Insight Imaging Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K904618

by Cardiovascular Imaging Systems, Inc.

Identifiers

510(k) Number
K904618 FDA 510(k)
FDA Product Code
DQO 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 CVIS Insight Imaging Catheter is an intravascular diagnostic catheter (product code DQO), designed for imaging within blood vessels. It facilitates real-time visualization of coronary and peripheral vasculature, aiding in the assessment of arterial structure and potential obstructions during interventional procedures.

This device is intended for single-use and is supplied sterile. It is classified as Class II under FDA regulations, with a traditional 510(k) clearance (K904618) issued in 1991. The catheter is intended for use in clinical settings where intravascular imaging is required, adhering to standard sterility and handling protocols for diagnostic catheters.

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 (K905625) — FDA 510(k) | Innolitics, CVIS INSIGHT IMAGING CATHETER (K897153) — FDA 510(k) | Innolitics, K904618 FDA 510 (k) - CVIS INSIGHT IMAGING CATHETER, K930232 FDA 510 (k) - CVIS INSIGHT IMAGING GUIDE 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) K904618 24 fields · synced Sep 19, 2026