Cleared Special

K040173 - PEDIATRIC AORTIC ROOT CANNULA

K040173 is an FDA 510(k) clearance for PEDIATRIC AORTIC ROOT CANNULA, manufactured by Medtronic Perfusion Systems. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Special 510(k) pathway after a 53-day FDA review.

K040173 · Medtronic Perfusion Systems · Cardiovascular device
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Mar 2004
Decision
53d
Days
Class 2
Risk

K040173 is an FDA 510(k) clearance for the PEDIATRIC AORTIC ROOT CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on March 19, 2004 after a review of 53 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 Medtronic Perfusion Systems devices

FDA 510(k) Submission Details - K040173

510(k) Number K040173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2004
Decision Date March 19, 2004
Days to Decision 53 days
Submission Type Special
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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 269
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K040173.
SELECT 3D ARTERIAL CANNULA
K043179 · Medtronic Perfusion Systems · Feb 2005
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
K033463 · Edwards Lifesciences, LLC · Jul 2004
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
K033464 · Edwards Lifesciences, LLC · Jun 2004
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
K034058 · Medtronic Vascular · Jan 2004
SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE
K033416 · Medtronic Perfusion Systems · Nov 2003
MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES
K033264 · Medtronic Perfusion Systems · Oct 2003