510(k) K122590

RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE by Terumo Medical Corporation — Product Code DQX

K122590 is an FDA 510(k) premarket notification submitted by Terumo Medical Corporation for the device "RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE". The FDA issued a decision of Substantially Equivalent on March 1, 2013. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Terumo Medical Corporation has at least 10 other 510(k) clearances on record.