MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC BIO-MEDICUS, INC.

The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Medtronic Bio-medicus Femoral Cannula/introducer.

Pre-market Notification Details

Device IDK924642
510k NumberK924642
Device Name:MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie,  MN  55344
ContactThomas K Johnsen
CorrespondentThomas K Johnsen
MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie,  MN  55344
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-14
Decision Date1993-03-26

NIH GUDID Devices

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