The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Prowler Select Lp Es Microcatheter; Prowler Xs Microcatheter.
| Device ID | K214025 |
| 510k Number | K214025 |
| Device Name: | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter |
| Classification | Catheter, Continuous Flush |
| Applicant | Medos International Sarl Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Ivenette Guzman |
| Correspondent | Ivenette Guzman 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 | 2021-12-22 |
| Decision Date | 2022-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704085614 | K214025 | 000 |
| 10886704085607 | K214025 | 000 |
| 10886704085591 | K214025 | 000 |
| 10886704085584 | K214025 | 000 |