Device Classification Name |
System, Balloon, Intra-Aortic And Control
|
510(k) Number |
K965236 |
Device Name |
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) |
Applicant |
DATASCOPE CORP. |
580 WINTERS AVE. |
PARAMUS,
NJ
07652
|
|
Applicant Contact |
WILLIAM GOELLER |
Correspondent |
DATASCOPE CORP. |
580 WINTERS AVE. |
PARAMUS,
NJ
07652
|
|
Correspondent Contact |
WILLIAM GOELLER |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 12/31/1996 |
Decision Date | 07/01/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|