INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY


Device Classification Name

oxygenator, cardiopulmonary bypass

510(k) Number K022450
Device Name INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
Original Applicant
DIDECO S.P.A.
195 west st.
waltham, 
MA 
02451 -1163

Original Contact barry sall
Regulation Number 870.4350
Classification Product Code
DTZ  
Date Received 07/26/2002
Decision Date 10/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No