K241177 is an FDA 510(k) clearance for the React 71 Catheter. 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 May 28, 2024, 29 days after receiving the submission on April 29, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K241177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2024 |
| Decision Date | May 28, 2024 |
| Days to Decision | 29 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 |