ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K073631
Device Name ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
Applicant
ORQIS MEDICAL CORPORATION
14 orchard road, suite 100
lake forest, 
CA 
92630

Applicant Contact ryan kelly
Correspondent
ORQIS MEDICAL CORPORATION
14 orchard road, suite 100
lake forest, 
CA 
92630

Correspodent Contact ryan kelly
Regulation Number 870.4360
Classification Product Code
KFM  
Date Received 12/26/2007
Decision Date 06/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No