510(k) K193125

R2P Destination Slender Guiding Sheath by Terumo Medical Corporation — Product Code DYB

K193125 is an FDA 510(k) premarket notification submitted by Terumo Medical Corporation for the device "R2P Destination Slender Guiding Sheath". The FDA issued a decision of Substantially Equivalent on January 6, 2020. 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.