CENTRIMAG RETURN CANNULA KIT

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

LEVITRONIX LLC.

The following data is part of a premarket notification filed by Levitronix Llc. with the FDA for Centrimag Return Cannula Kit.

Pre-market Notification Details

Device IDK110980
510k NumberK110980
Device Name:CENTRIMAG RETURN CANNULA KIT
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant LEVITRONIX LLC. 45 FIRST AVE. Waltham,  MA  02451
ContactLydia Sakakeeny
CorrespondentLydia Sakakeeny
LEVITRONIX LLC. 45 FIRST AVE. Waltham,  MA  02451
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-07
Decision Date2011-06-20
Summary:summary

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