PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30


Device Classification Name

heat-exchanger, cardiopulmonary bypass

510(k) Number K072583
Device Name PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
Applicant
MAQUET CARDIOPULMONARY AG
hechinger strasse 38
hirrlingen, 

DE

72145

Applicant Contact katrin schwenkglenks
Correspondent
MAQUET CARDIOPULMONARY AG
hechinger strasse 38
hirrlingen, 

DE

72145

Correspodent Contact katrin schwenkglenks
Regulation Number 870.4240
Classification Product Code
DTR  
Date Received 09/13/2007
Decision Date 04/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No