510(k) K171251

014 Hydrophilic Coated PTA Balloon Dilatation Catheter by Creagh Medical — Product Code LIT

K171251 is an FDA 510(k) premarket notification submitted by Creagh Medical for the device "014 Hydrophilic Coated PTA Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on September 8, 2017. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Creagh Medical has at least 5 other 510(k) clearances on record.