510(k) K172995

Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath by Terumo Medical Corporation — Product Code DYB

K172995 is an FDA 510(k) premarket notification submitted by Terumo Medical Corporation for the device "Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath". The FDA issued a decision of Substantially Equivalent on November 21, 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.