BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE

Control, Pump Speed, Cardiopulmonary Bypass

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Bio-console 560 Extracorporeal Blood Pumping Console.

Pre-market Notification Details

Device IDK131964
510k NumberK131964
Device Name:BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactLisa Stone
CorrespondentLisa Stone
MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-27
Decision Date2013-07-24
Summary:summary

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