510(k) K200700

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter by Creagh Medical, Ltd. — Product Code LIT

K200700 is an FDA 510(k) premarket notification submitted by Creagh Medical, Ltd. for the device "Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on May 14, 2020. 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.