CENTRIMAG RETURN CANNULA KIT


Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K110980
Device Name CENTRIMAG RETURN CANNULA KIT
Applicant
LEVITRONIX LLC.
45 first ave.
waltham, 
MA 
02451

Applicant Contact lydia sakakeeny
Correspondent
LEVITRONIX LLC.
45 first ave.
waltham, 
MA 
02451

Correspodent Contact lydia sakakeeny
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 04/07/2011
Decision Date 06/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No