Device Classification Name |
System, Balloon, Intra-Aortic And Control
|
510(k) Number |
K172305 |
Device Name |
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump |
Applicant |
Datascope Corp. |
1300 MacArthur Blvd. |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Helder A. Sousa |
Correspondent |
Datascope Corp. |
1300 MacArthur Blvd. |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Helder A. Sousa |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 07/31/2017 |
Decision Date | 10/12/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|