K252122 is an FDA 510(k) clearance for the DCwire Micro-guidewire. This device is classified as a Guide, Wire, Catheter, Neurovasculature (Class II - Special Controls, product code MOF).
Submitted by Shanghai Achieva Medical Suzhou Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on March 16, 2026, 252 days after receiving the submission on July 7, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K252122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2025 |
| Decision Date | March 16, 2026 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MOF — Guide, Wire, Catheter, Neurovasculature |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |