510(k) K150946

FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm by Ostial Corporation — Product Code LIT

K150946 is an FDA 510(k) premarket notification submitted by Ostial Corporation for the device "FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm". The FDA issued a decision of Substantially Equivalent on May 8, 2015. 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.