Bio-Medicus Adult Cannulae Kit

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 Adult Cannulae Kit.

Pre-market Notification Details

Device IDK180456
510k NumberK180456
Device Name:Bio-Medicus Adult Cannulae Kit
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant Medtronic Inc. 8200 Coral Street NE Mounds View,  MN  55112
ContactHuda Yusuf
CorrespondentHuda Yusuf
Medtronic Inc. 8200 Coral Street NE Mounds View,  MN  55112
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-20
Decision Date2018-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000116187 K180456 000
00763000060527 K180456 000
00763000060534 K180456 000
00763000060541 K180456 000
00763000060558 K180456 000
00763000060565 K180456 000
00763000116132 K180456 000
00763000116149 K180456 000
00763000116156 K180456 000
00763000116163 K180456 000
00763000116170 K180456 000
00763000060572 K180456 000

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