510(k) K143041

Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter by Natec Medical , Ltd. — Product Code LIT

K143041 is an FDA 510(k) premarket notification submitted by Natec Medical , Ltd. for the device "Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter". The FDA issued a decision of Substantially Equivalent on June 4, 2015. 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.