510(k) K133861

FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM by Ostial Corporation — Product Code LIT

K133861 is an FDA 510(k) premarket notification submitted by Ostial Corporation for the device "FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM". The FDA issued a decision of Substantially Equivalent on July 2, 2014. 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.