Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K821065 |
Device Name |
DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL |
Applicant |
DATASCOPE CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DATASCOPE CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 04/15/1982 |
Decision Date | 08/19/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|