510(k) K122980

GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ by Terumo Medical Corporation — Product Code DYB

K122980 is an FDA 510(k) premarket notification submitted by Terumo Medical Corporation for the device "GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ". The FDA issued a decision of Substantially Equivalent on December 11, 2012. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Terumo Medical Corporation has at least 10 other 510(k) clearances on record.