LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902


the company

Device Classification Name

oxygenator, cardiopulmonary bypass

510(k) Number K001021
Device Name LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
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 03/30/2000
Decision Date 04/25/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No