CARPENTIER BI-CAVAL FEMORAL CANNULA

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 Carpentier Bi-caval Femoral Cannula.

Pre-market Notification Details

Device IDK140192
510k NumberK140192
Device Name:CARPENTIER BI-CAVAL FEMORAL CANNULA
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC, INC. 7611 NORTHLAND DRIVE Brooklyn Park,  MN  55428
ContactJacqueline A Hauge
CorrespondentJacqueline A Hauge
MEDTRONIC, INC. 7611 NORTHLAND DRIVE Brooklyn Park,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-27
Decision Date2014-05-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169697614 K140192 000
00643169697607 K140192 000
00643169697591 K140192 000
00643169697584 K140192 000
20643169490134 K140192 000
20643169490127 K140192 000
20643169490110 K140192 000
20643169490103 K140192 000

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