CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR

Control, Pump Speed, Cardiopulmonary Bypass

THORATEC CORP

The following data is part of a premarket notification filed by Thoratec Corp with the FDA for Centrimag Primary Console (2nd Generation); Mag Monitor.

Pre-market Notification Details

Device IDK131179
510k NumberK131179
Device Name:CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant THORATEC CORP 23 4th Ave Burlington,  MA  01803
ContactYverre Bobay
CorrespondentYverre Bobay
THORATEC CORP 23 4th Ave Burlington,  MA  01803
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-25
Decision Date2013-07-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.