IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K030154
Device Name IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
Original Applicant
DIDECO S.P.A.
195 west st.
waltham, 
MA 
02451 -1163

Original Contact barry sall
Regulation Number 870.4360
Classification Product Code
KFM  
Date Received 01/16/2003
Decision Date 03/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No