D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS


Device Classification Name

filter, blood, cardiopulmonary bypass, arterial line

510(k) Number K112525
Device Name D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
Applicant
PAREXELINTERNATIONAL
195 west street
waltham, 
MA 
02451

Applicant Contact barry sall
Correspondent
PAREXELINTERNATIONAL
195 west street
waltham, 
MA 
02451

Correspodent Contact barry sall
Regulation Number 870.4260
Classification Product Code
DTM  
Date Received 08/31/2011
Decision Date 09/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No