Device Classification Name |
clamp, vascular
|
510(k) Number |
K122405 |
Device Name |
AIR-BAND RADIAL COMPRESSION DEVICE |
Applicant |
DATASCOPE CORP., CARDIAC ASSIST DIVISION |
15 LAW DR. |
FAIRFIELD,
NJ
07004 -0011
|
|
Applicant Contact |
CARLA S CERQUEIRA |
Correspondent |
DATASCOPE CORP., CARDIAC ASSIST DIVISION |
15 LAW DR. |
FAIRFIELD,
NJ
07004 -0011
|
|
Correspondent Contact |
CARLA S CERQUEIRA |
Regulation Number | 870.4450
|
Classification Product Code |
|
Date Received | 08/07/2012 |
Decision Date | 11/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|