K251915 is an FDA 510(k) clearance for the Amethyst HP PTA OTW 0.035 Catheter. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Natec Medical , Ltd. (Moka, MU). The FDA issued a Cleared decision on December 18, 2025, 178 days after receiving the submission on June 23, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K251915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2025 |
| Decision Date | December 18, 2025 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |