Thoratec CentriMag Return (Arterial) Cannula Kit

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Thoratec Corporation

The following data is part of a premarket notification filed by Thoratec Corporation with the FDA for Thoratec Centrimag Return (arterial) Cannula Kit.

Pre-market Notification Details

Device IDK152161
510k NumberK152161
Device Name:Thoratec CentriMag Return (Arterial) Cannula Kit
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant Thoratec Corporation 6035 Stoneridge Drive Pleasanton,  CA  94588
ContactLori Dondiego
CorrespondentLori Dondiego
Thoratec Corporation 6035 Stoneridge Drive Pleasanton,  CA  94588
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-03
Decision Date2015-09-18
Summary:summary

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