BIO-CONSOLE, MODEL 560

Control, Pump Speed, Cardiopulmonary Bypass

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Bio-console, Model 560.

Pre-market Notification Details

Device IDK051303
510k NumberK051303
Device Name:BIO-CONSOLE, MODEL 560
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N Minneapolis,  MN  55428
ContactDawn M Stenstrom
CorrespondentDawn M Stenstrom
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N Minneapolis,  MN  55428
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-19
Decision Date2005-06-10
Summary:summary

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