Bio-Medicus Life Support Catheter And Introducer

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Medtronic Inc.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Bio-medicus Life Support Catheter And Introducer.

Pre-market Notification Details

Device IDK201100
510k NumberK201100
Device Name:Bio-Medicus Life Support Catheter And Introducer
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant Medtronic Inc. 8200 Coral Sea St. NE Mounds Views,  MN  55112
ContactJuli Rubin
CorrespondentJuli Rubin
Medtronic Inc. 8200 Coral Sea St. NE Mounds Views,  MN  55112
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-24
Decision Date2021-07-15

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