DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER


codes

Device Classification Name

filter, blood, cardiopulmonary bypass, arterial line

510(k) Number K002493
Device Name DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
Original Applicant
COBE CARDIOVASCULAR, INC.
14401 west 65th way
arvada, 
CO 
80004

Original Contact lynne leonard
Regulation Number 870.4260
Classification Product Code
DTM  
Date Received 08/14/2000
Decision Date 11/30/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No