The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Prowler Select Plus; Prowler Ex.
| Device ID | K210838 |
| 510k Number | K210838 |
| Device Name: | PROWLER SELECT PLUS; PROWLER EX |
| Classification | Catheter, Continuous Flush |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Samuel Shimp |
| Correspondent | Samuel Shimp Cerenovus 6303 Blue Lagoon Drive; Suite 315 Miami, FL 33126 |
| Product Code | KRA |
| Subsequent Product Code | DQY |
| Subsequent Product Code | QJP |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-22 |
| Decision Date | 2021-08-25 |