Bio-Medicus Adult Cannulae 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 Adult Cannulae And Introducer.

Pre-market Notification Details

Device IDK180453
510k NumberK180453
Device Name:Bio-Medicus Adult Cannulae And Introducer
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
00763000193522 K180453 000
00763000060596 K180453 000
00763000060602 K180453 000
00763000060619 K180453 000
00763000060626 K180453 000
00763000060633 K180453 000
00763000193492 K180453 000
00763000193508 K180453 000
00763000193515 K180453 000
00763000060589 K180453 000

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