Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K002949 |
Device Name |
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC |
Applicant |
DATASCOPE CORP. |
15 LAW DR. |
FAIRFIELD,
NJ
07004 -3206
|
|
Applicant Contact |
JOANNE WOLF |
Correspondent |
DATASCOPE CORP. |
15 LAW DR. |
FAIRFIELD,
NJ
07004 -3206
|
|
Correspondent Contact |
JOANNE WOLF |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 09/21/2000 |
Decision Date | 10/20/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|