K251181 is an FDA 510(k) clearance for the Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5). This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Merit Medical Ireland, Ltd. (Galway, IE). The FDA issued a Cleared decision on August 29, 2025, 135 days after receiving the submission on April 16, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K251181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2025 |
| Decision Date | August 29, 2025 |
| Days to Decision | 135 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX - Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |