MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Mc2x Multi-stage Venous Cannula, Models 91437, 91437c.

Pre-market Notification Details

Device IDK052372
510k NumberK052372
Device Name:MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
ContactRonald W Bennett
CorrespondentRonald W Bennett
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-30
Decision Date2005-09-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169159280 K052372 000
00643169159273 K052372 000
20613994887058 K052372 000
20613994887041 K052372 000

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