K210838 is an FDA 510(k) clearance for the PROWLER SELECT PLUS. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on August 25, 2021, 156 days after receiving the submission on March 22, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K210838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2021 |
| Decision Date | August 25, 2021 |
| Days to Decision | 156 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |