The following data is part of a premarket notification filed by Arrow International, Inc. with the FDA for Fiberoptix Iab.
| Device ID | K190117 |
| 510k Number | K190117 |
| Device Name: | Fiberoptix IAB |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | Arrow International, Inc. 16 Elizabeth Drive Chelmsford, MA 01824 |
| Contact | Niyati Boghani |
| Correspondent | Niyati Boghani Arrow International, Inc. 16 Elizabeth Drive Chelmsford, MA 01824 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-24 |
| Decision Date | 2019-06-13 |