K221279 is an FDA 510(k) clearance for the pNOVUS 21 Microcatheter. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Phenox, Ltd. (Galway, IE). The FDA issued a Cleared decision on November 28, 2022, 209 days after receiving the submission on May 3, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K221279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2022 |
| Decision Date | November 28, 2022 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQO - Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |