The following data is part of a premarket notification filed by Reflow Medical, Inc. with the FDA for Wingman 14c Crossing Catheter.
| Device ID | K190393 |
| 510k Number | K190393 |
| Device Name: | Wingman 14C Crossing Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | ReFlow Medical, Inc. 208 Avenida Fabricante #100 San Clemente, CA 92672 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine ReFlow Medical, Inc. 208 Avenida Fabricante #100 San Clemente, CA 92672 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-05-09 |