Bio-Medicus Pediatric Cannula And Introducers

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 Pediatric Cannula And Introducers.

Pre-market Notification Details

Device IDK143083
510k NumberK143083
Device Name:Bio-Medicus Pediatric Cannula And Introducers
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC, INC 8200 CORAL ST NE Mounds View,  MN  55112
ContactBruce Backlund
CorrespondentBruce Backlund
MEDTRONIC, INC 8200 CORAL ST NE Mounds View,  MN  55112
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-27
Decision Date2015-03-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169623163 K143083 000
00763000116309 K143083 000
00763000116316 K143083 000
00763000116323 K143083 000
00763000116330 K143083 000
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00643169623095 K143083 000
00643169623101 K143083 000
00643169623118 K143083 000
00643169623125 K143083 000
00643169623132 K143083 000
00643169623149 K143083 000
00643169623156 K143083 000
00763000116293 K143083 000

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