BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT

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 Bio-medicus Multi-stage Venous Femoral Percutaneous Kit.

Pre-market Notification Details

Device IDK052524
510k NumberK052524
Device Name:BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
ContactBruce Backlund
CorrespondentBruce Backlund
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2005-09-14
Decision Date2005-11-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169086371 K052524 000
00643169086364 K052524 000
00643169086357 K052524 000
00763000242367 K052524 000
00763000242350 K052524 000
00763000242343 K052524 000

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