Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K041281 |
Device Name |
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES |
Applicant |
DATASCOPE CORP. |
15 LAW DR. |
FAIRFIELD,
NJ
07004 -3206
|
|
Applicant Contact |
JOANN TAYLOR |
Correspondent |
DATASCOPE CORP. |
15 LAW DR. |
FAIRFIELD,
NJ
07004 -3206
|
|
Correspondent Contact |
JOANN TAYLOR |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 05/13/2004 |
Decision Date | 06/07/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|