510(k) K113335

HEARTRAIL III GUIDING CATHETER by Terumo Corporation — Product Code DQO

K113335 is an FDA 510(k) premarket notification submitted by Terumo Corporation for the device "HEARTRAIL III GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on Jul 16, 2012. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Terumo Corporation has at least 10 other 510(k) clearances on record.