Cleared Traditional

K013593 - CARDEON AEGIS CATHETER

K013593 is an FDA 510(k) clearance for CARDEON AEGIS CATHETER, manufactured by Cardeon Corp.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K013593 · Cardeon Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
237d
Days
Class 2
Risk

K013593 is an FDA 510(k) clearance for the 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 June 24, 2002 after a review of 237 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K013593

510(k) Number K013593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2001
Decision Date June 24, 2002
Days to Decision 237 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 125d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 397
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K013593.
MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)
K022042 · Cardeon Corp. · Sep 2002
3T VESSEL CANNULAS
K020768 · 3t Medical Systems, LLC · Aug 2002
MODIFICATION TO CARDEON AEGIS CATHETER
K022174 · Cardeon Corp. · Jul 2002
JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA
K020515 · Jostra AG · Apr 2002
AXILLARY ACCESS ARTERIAL CANNULA
K002578 · Edwards Lifesciences, LLC · Apr 2002
JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
K014303 · Jostra AG · Mar 2002
K013593 · CARDEON AEGIS CATHETER
Download PDF FDA Summary Cardeon Corp.