510(k) K152230

Ebony PTA .014 RX Pheripheral Dilatation Catheter by Natec Medical — Product Code LIT

K152230 is an FDA 510(k) premarket notification submitted by Natec Medical for the device "Ebony PTA .014 RX Pheripheral Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on September 3, 2015. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Natec Medical has at least 10 other 510(k) clearances on record.