Device Classification Name |
System, Balloon, Intra-Aortic And Control
|
510(k) Number |
K031636 |
Device Name |
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX |
Applicant |
DATASCOPE CORP. |
800 MACARTHUR BLVD. |
MAHWAH,
NJ
07430 -0619
|
|
Applicant Contact |
SUSAN MANDY |
Correspondent |
DATASCOPE CORP. |
800 MACARTHUR BLVD. |
MAHWAH,
NJ
07430 -0619
|
|
Correspondent Contact |
SUSAN MANDY |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 05/27/2003 |
Decision Date | 08/11/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|