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Cvis Insight Imaging Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K897153

by Cardiovascular Imaging Systems, Inc.

Identifiers

510(k) Number
K897153 FDA 510(k)
FDA Product Code
LYK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cvis Insight Imaging Catheter is an Angioscope, a type of intravascular diagnostic catheter. It is used for imaging purposes. The device is classified as a Class 2 device with the product code LYK.

The Cvis Insight Imaging Catheter is supplied by Cardiovascular Imaging Systems, Inc. It has received FDA 510K authorization. The device is associated with the medical specialty descriptions Gastroenterology and Urology.

Frequently asked questions

What is the CVIS Insight Imaging Catheter used for?

The CVIS Insight Imaging Catheter is used for imaging purposes, specifically as an intravascular diagnostic catheter.

What medical specialties is the device associated with?

The CVIS Insight Imaging Catheter is associated with the medical specialty descriptions Gastroenterology and Urology.

What type of authorization has the device received?

The CVIS Insight Imaging Catheter has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device.

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, K905625 FDA 510 (k) - CVIS INSIGHT IMAGING CATHETER, K904618 FDA 510 (k) - CVIS INSIGHT IMAGING CATHETER, CVIS INSIGHT IMAGING CATHETER 510 (k) K901562 - FDA.report

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) K897153 24 fields · synced Oct 1, 2026