Bio-Medicus Adult Cannulae And Introducer

Catheter, Percutaneous

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 IDK142673
510k NumberK142673
Device Name:Bio-Medicus Adult Cannulae And Introducer
ClassificationCatheter, Percutaneous
Applicant Medtronic, Inc 8200 Coral Sea St. NE Mounds View,  MN  55112
ContactBruce Backlund
CorrespondentBruce Backlund
Medtronic, Inc 8200 Coral Sea St. NE Mounds View,  MN  55112
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-19
Decision Date2014-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00643169025943 K142673 000
00643169025936 K142673 000
00763000116071 K142673 000

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