SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045


Device Classification Name

reservoir, blood, cardiopulmonary bypass

510(k) Number K022281
Device Name SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
Original Applicant
POLYSTAN A/S
walgerholm 8
vaerlose, 

DK

dk-3500

Original Contact dana olsen
Regulation Number 870.4400
Classification Product Code
DTN  
Date Received 07/15/2002
Decision Date 08/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No