Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K132829 |
Device Name |
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS |
Applicant |
MAQUET CARDIOPULMONARY AG |
45 BARBOUR POND DRIVE |
WAYNE,
NJ
07470
|
|
Applicant Contact |
WHITNEY TORNING |
Correspondent |
MAQUET CARDIOPULMONARY AG |
45 BARBOUR POND DRIVE |
WAYNE,
NJ
07470
|
|
Correspondent Contact |
WHITNEY TORNING |
Regulation Number | 870.4350
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/09/2013 |
Decision Date | 10/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|