510(k) K251915

Amethyst HP PTA OTW 0.035 Catheter by Natec Medical , Ltd. — Product Code LIT

K251915 is an FDA 510(k) premarket notification submitted by Natec Medical , Ltd. for the device "Amethyst HP PTA OTW 0.035 Catheter". The FDA issued a decision of Substantially Equivalent on December 18, 2025. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Natec Medical , Ltd. has at least 10 other 510(k) clearances on record.