QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES


Device Classification Name

oxygenator, cardiopulmonary bypass

510(k) Number K112360
Device Name QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES
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 870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTM   DTR   KFM  
Date Received 08/17/2011
Decision Date 09/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls