SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI


Device Classification Name

oxygenator, cardiopulmonary bypass

510(k) Number K073380
Device Name SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI
Applicant
SORIN GROUP ITALIA S.R.L.
200 west street
waltham, 
MA 
02451

Applicant Contact barry sall
Correspondent
SORIN GROUP ITALIA S.R.L.
200 west street
waltham, 
MA 
02451

Correspodent Contact barry sall
Regulation Number 870.4350
Classification Product Code
DTZ  
Date Received 12/03/2007
Decision Date 02/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls