Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K020257 |
Device Name |
DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S |
Applicant |
DATASCOPE CORP. |
15 LAW DR. |
FAIRFIELD,
NJ
07004 -3206
|
|
Applicant Contact |
JOANN WOLF |
Correspondent |
DATASCOPE CORP. |
15 LAW DR. |
FAIRFIELD,
NJ
07004 -3206
|
|
Correspondent Contact |
JOANN WOLF |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 01/24/2002 |
Decision Date | 04/24/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|