510(k) K112629

ONSET ACCESS CATHETER SYSTEM by Onset Medical Corporation — Product Code DQY

K112629 is an FDA 510(k) premarket notification submitted by Onset Medical Corporation for the device "ONSET ACCESS CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on October 11, 2011. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Onset Medical Corporation has at least 7 other 510(k) clearances on record.