510(k) K180007

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter by Creagh Medical, Ltd. — Product Code LIT

K180007 is an FDA 510(k) premarket notification submitted by Creagh Medical, Ltd. for the device "018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on April 19, 2018. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Creagh Medical, Ltd. has at least 5 other 510(k) clearances on record.