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Modification to Cardeon Aegis Catheter

by Cardeon Corp. 2 variants

510(k) K024058

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK024058 Date30 Dec 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a modification to the Cardeon Aegis Catheter, classified as a catheter, cannula and tubing, vascular, cardiopulmonary bypass. It is intended for use in perfusing the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass.

The device is supplied non-sterile and is reusable. It has received FDA 510(k) clearance under K024058, with a decision date of 2002-12-30, and is classified as a Class II medical device under regulation 870.4210. The product code is DWF, and it is manufactured by Cardeon Corp. in Cupertino, CA.

Other devices from Cardeon Corp.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Modification to Cardeon Aegis Catheter used for?

    It is intended for use in perfusing the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass, as a vascular cannula and tubing device.

  • Is the Modification to Cardeon Aegis Catheter sterile or non-sterile when supplied?

    The device is supplied non-sterile, meaning it must be sterilized by the user before clinical use, as indicated in the device specifications.

  • Can the Modification to Cardeon Aegis Catheter be reused after use?

    Yes, the device is designed for reuse, as explicitly stated in the description that it is supplied non-sterile and is reusable.

  • What regulatory pathway was used for the Modification to Cardeon Aegis Catheter?

    The device received FDA 510(k) clearance under K024058, with a decision date of 2002-12-30, and is classified as a Class II medical device under regulation 870.4210.

  • What is the product code and classification for the Modification to Cardeon Aegis Catheter?

    The product code is DWF, and it is classified as a Class II device under regulation 870.4210, with the device name 'Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass'.