510(k) K171491

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

K171491 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 October 5, 2017. 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.