The following data is part of a premarket notification filed by Promepla Sam with the FDA for Bi-flex Evo.
| Device ID | K182144 |
| 510k Number | K182144 |
| Device Name: | Bi-Flex Evo |
| Classification | Accessories, Catheter, G-u |
| Applicant | Promepla Sam 9 Avenue Albert II Monaco, MC 98000 |
| Contact | Alexandre Bareille |
| Correspondent | Alexandre Bareille Promepla Sam 9 Avenue Albert II Monaco, MC 98000 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-08 |
| Decision Date | 2018-09-07 |
| Summary: | summary |