SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE

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 Select 3d Arterial Cannula With Carmeda Bioactive Surface And Select Cap Arterial Cannula With Carmeda Bioactive Surface.

Pre-market Notification Details

Device IDK033416
510k NumberK033416
Device Name:SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Brooklyn Park,  MN  55428
ContactRonald W Bennett
CorrespondentRonald W Bennett
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Brooklyn Park,  MN  55428
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-27
Decision Date2003-11-05
Summary:summary

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