Cleared Special

K052372 - MC2X MULTI-STAGE VENOUS CANNULA

K052372 is an FDA 510(k) clearance for MC2X MULTI-STAGE VENOUS 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 23-day FDA review.

K052372 · Medtronic Perfusion Systems · Cardiovascular device
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Sep 2005
Decision
23d
Days
Class 2
Risk

K052372 is an FDA 510(k) clearance for the MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C. 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 September 22, 2005 after a review of 23 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 - K052372

510(k) Number K052372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2005
Decision Date September 22, 2005
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
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 283
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K052372.
JOSTRA HLM TUBING SETS WITH SAFELINE COATING
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EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222
K061254 · Medtronic Perfusion Systems · Jun 2006
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
K052524 · Medtronic Perfusion Systems · Nov 2005
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