The following data is part of a premarket notification filed by Reflow Medical, Inc. with the FDA for Wingman 18 Crossing Catheter.
| Device ID | K160848 |
| 510k Number | K160848 |
| Device Name: | Wingman 18 Crossing Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | ReFlow Medical, Inc. 1003 Calle Sombra San Clemente, CA 92673 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine ReFlow Medical, Inc. 1003 Calle Sombra San Clemente, CA 92673 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-28 |
| Decision Date | 2016-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856492005289 | K160848 | 000 |
| 00856492005272 | K160848 | 000 |
| 00856492005265 | K160848 | 000 |