Device Classification Name |
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
|
510(k) Number |
K011835 |
Device Name |
COBE REVOLUTION |
Applicant |
COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY |
ARVADA,
CO
80004
|
|
Applicant Contact |
LYNNE LEONARD |
Correspondent |
COBE CARDIOVASCULAR, INC. |
14401 WEST 65TH WAY |
ARVADA,
CO
80004
|
|
Correspondent Contact |
LYNNE LEONARD |
Regulation Number | 870.4360
|
Classification Product Code |
|
Date Received | 06/12/2001 |
Decision Date | 02/12/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|