K210230 is an FDA 510(k) clearance for the Phenom Catheters. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on February 25, 2021, 28 days after receiving the submission on January 28, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K210230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2021 |
| Decision Date | February 25, 2021 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |