Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K914802 |
Device Name |
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL |
Applicant |
DATASCOPE CORP. |
3 FIR CT. |
P.O. BOX 3100 |
OAKLAND,
NJ
07436
|
|
Applicant Contact |
BILL CORRIGAN |
Correspondent |
DATASCOPE CORP. |
3 FIR CT. |
P.O. BOX 3100 |
OAKLAND,
NJ
07436
|
|
Correspondent Contact |
BILL CORRIGAN |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 10/24/1991 |
Decision Date | 08/25/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|