LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE

Control, Pump Speed, Cardiopulmonary Bypass

LEVITRONIX LLC.

The following data is part of a premarket notification filed by Levitronix Llc. with the FDA for Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console.

Pre-market Notification Details

Device IDK083340
510k NumberK083340
Device Name:LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant LEVITRONIX LLC. 45 FIRST AVE. Waltham,  MA  02451
ContactSusan Hamann
CorrespondentSusan Hamann
LEVITRONIX LLC. 45 FIRST AVE. Waltham,  MA  02451
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-12
Decision Date2008-11-26
Summary:summary

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