EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE

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 Eopa Elongated One-piece Arterial Cannula And Guidewire.

Pre-market Notification Details

Device IDK031037
510k NumberK031037
Device Name:EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55428 -1088
ContactRonald W Bennett
CorrespondentRonald W Bennett
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55428 -1088
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-01
Decision Date2003-05-13
Summary:summary

NIH GUDID Devices

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