Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K190117 |
Device Name |
Fiberoptix IAB |
Applicant |
Arrow International, Inc. |
16 Elizabeth Drive |
Chelmsford,
MA
01824
|
|
Applicant Contact |
Niyati Boghani |
Correspondent |
Arrow International, Inc. |
16 Elizabeth Drive |
Chelmsford,
MA
01824
|
|
Correspondent Contact |
Niyati Boghani |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 01/24/2019 |
Decision Date | 06/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|