510(k) K120781

CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH by Fuji Systems Corp. — Product Code DQY

K120781 is an FDA 510(k) premarket notification submitted by Fuji Systems Corp. for the device "CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH". The FDA issued a decision of Substantially Equivalent on Aug 9, 2012. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Fuji Systems Corp. has 1 other 510(k) clearance on record.