MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE

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 Mc2 Two-stage Venous Cannula, Oval Mc2 Two-stage Venous Cannula, Thin Wall Two-stage Venous Cannula, Mc2x Three-stage Ve.

Pre-market Notification Details

Device IDK140165
510k NumberK140165
Device Name:MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
ContactJacqueline A Hauge
CorrespondentJacqueline A Hauge
MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-22
Decision Date2014-05-20
Summary:summary

NIH GUDID Devices

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