The following data is part of a premarket notification filed by Reflow Medical with the FDA for Wingman Crossing Catheter.
| Device ID | K151880 |
| 510k Number | K151880 |
| Device Name: | Wingman Crossing Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | REFLOW MEDICAL 1003 CALLE SOMBRA San Clemente, CA 92673 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine REFLOW MEDICAL 1003 CALLE SOMBRA San Clemente, CA 92673 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-09 |
| Decision Date | 2015-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856492005258 | K151880 | 000 |
| 00856492005241 | K151880 | 000 |
| 00856492005234 | K151880 | 000 |