510(k) K063372

RADIFOCUS GLIDEWIRE ADVANTAGE by Terumo Medical Corp. — Product Code DQX

K063372 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "RADIFOCUS GLIDEWIRE ADVANTAGE". The FDA issued a decision of Substantially Equivalent on January 19, 2007. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Terumo Medical Corp. has at least 10 other 510(k) clearances on record.