MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Malleable Single Stage Venous Cannula With Carmeda Bioactive Surface, Model Cb681xx Series.

Pre-market Notification Details

Device IDK033264
510k NumberK033264
Device Name:MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
ContactPreeti Jain
CorrespondentPreeti Jain
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-09
Decision Date2003-10-31
Summary:summary

NIH GUDID Devices

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