510(k) K170193

Advance 14LP Low Profile PTA Balloon Dilatation Catheter by Cook Incorporated — Product Code LIT

K170193 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Advance 14LP Low Profile PTA Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on Feb 13, 2017. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Cook Incorporated has 174 other 510(k) clearances on record.