D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED


Device Classification Name

filter, blood, cardiopulmonary bypass, arterial line

510(k) Number K072308
Device Name D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED
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 870.4260
Classification Product Code
DTM  
Date Received 08/17/2007
Decision Date 09/12/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No