Cleared Special

K024058 - MODIFICATION TO CARDEON AEGIS CATHETER

K024058 is an FDA 510(k) clearance for MODIFICATION TO CARDEON AEGIS CATHETER, manufactured by Cardeon Corp.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Special 510(k) pathway after a 21-day FDA review.

K024058 · Cardeon Corp. · Cardiovascular device
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Dec 2002
Decision
21d
Days
Class 2
Risk

K024058 is an FDA 510(k) clearance for the MODIFICATION TO CARDEON AEGIS CATHETER. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Cardeon Corp. (Cupertino, US). The FDA issued a Cleared decision on December 30, 2002 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cardeon Corp. devices

FDA 510(k) Submission Details - K024058

510(k) Number K024058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2002
Decision Date December 30, 2002
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 322
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K024058.
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K024069 · Medtronic Vascular · Jan 2003
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
K023880 · Ethicon, Inc. · Dec 2002
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K023056 · Terumo Cardiovascular Systems Corp. · Nov 2002
AXILLARY ACCESS ARTERIAL CANNULA
K002578 · Edwards Lifesciences, LLC · Apr 2002