HLM TUBING SET WITH BIOLINE COATING


Device Classification Name

tubing, pump, cardiopulmonary bypass

510(k) Number K080592
Device Name HLM TUBING SET WITH BIOLINE COATING
Applicant
MAQUET CARDIOPULMONARY AG
hechinger strasse 38
hirrlingen, 

DE

72145

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

DE

72145

Correspodent Contact katrin schwenglenks
Regulation Number 870.4390
Classification Product Code
DWE  
Subsequent Product Codes
DTL   DWF  
Date Received 03/03/2008
Decision Date 09/11/2008
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