510(k) K240818

R2P Radifocus Glidewire Advantage by Terumo Corporation — Product Code DQX

K240818 is an FDA 510(k) premarket notification submitted by Terumo Corporation for the device "R2P Radifocus Glidewire Advantage". The FDA issued a decision of Substantially Equivalent on November 26, 2024. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Terumo Corporation has at least 10 other 510(k) clearances on record.