Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K192238 |
Device Name |
AC3 Series Intra-Aortic Balloon Pump (IABP) |
Applicant |
Arrow International, Teleflex |
16 Elizabeth Drive |
Chelmsford,
MA
01824
|
|
Applicant Contact |
Deb Fleetham |
Correspondent |
Arrow International, Teleflex |
16 Elizabeth Drive |
Chelmsford,
MA
01824
|
|
Correspondent Contact |
Deb Fleetham |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 08/19/2019 |
Decision Date | 11/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|