Cleared Special

K033416 - SELECT 3D ARTERIAL CANNULA WITH CARMEDA...

K033416 is an FDA 510(k) clearance for SELECT 3D ARTERIAL CANNULA WITH CARMEDA..., 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 9-day FDA review.

K033416 · Medtronic Perfusion Systems · Cardiovascular device
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Nov 2003
Decision
9d
Days
Class 2
Risk

K033416 is an FDA 510(k) clearance for the SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTE.... 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 November 5, 2003 after a review of 9 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 - K033416

510(k) Number K033416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2003
Decision Date November 05, 2003
Days to Decision 9 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
116d faster than avg
Panel avg: 125d · This submission: 9d
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 K033416.
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
K033464 · Edwards Lifesciences, LLC · Jun 2004
PEDIATRIC AORTIC ROOT CANNULA
K040173 · Medtronic Perfusion Systems · Mar 2004
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
K034058 · Medtronic Vascular · Jan 2004
MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES
K033264 · Medtronic Perfusion Systems · Oct 2003
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
K032041 · LeMaitre Vascular, Inc. · Aug 2003
MC2X MULTI-STAGE VENOUS CANNULA
K031776 · Medtronic Perfusion Systems · Jul 2003