LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG 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 Centrimag Primary Console.

Pre-market Notification Details

Device IDK081221
510k NumberK081221
Device Name:LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-30
Decision Date2008-06-19
Summary:summary

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