510(k) K143701

EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM by Volcano Corporation — Product Code OBJ

K143701 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM". The FDA issued a decision of Substantially Equivalent on August 26, 2015. The device falls under product code OBJ (Catheter, Ultrasound, Intravascular), a Class II device regulated under 21 CFR 870.1200. Volcano Corporation has at least 10 other 510(k) clearances on record.