Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K091449 |
Device Name |
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 |
Applicant |
DATASCOPE CORP., CARDIAC ASSIST DIVISION |
15 LAW DR. |
FAIRFIELD,
NJ
07004 -0011
|
|
Applicant Contact |
DOLLY MISTRY |
Correspondent |
DATASCOPE CORP., CARDIAC ASSIST DIVISION |
15 LAW DR. |
FAIRFIELD,
NJ
07004 -0011
|
|
Correspondent Contact |
DOLLY MISTRY |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 05/18/2009 |
Decision Date | 06/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|