510(k) K121175

FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM by Ostial Corporation — Product Code LIT

K121175 is an FDA 510(k) premarket notification submitted by Ostial Corporation for the device "FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM". The FDA issued a decision of Substantially Equivalent on June 29, 2012. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Ostial Corporation has at least 10 other 510(k) clearances on record.