510(k) K202167

Brite Tip Radianz Guiding Sheath by Cordis Corporation — Product Code DYB

K202167 is an FDA 510(k) premarket notification submitted by Cordis Corporation for the device "Brite Tip Radianz Guiding Sheath". The FDA issued a decision of Substantially Equivalent on February 26, 2021. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Cordis Corporation has at least 10 other 510(k) clearances on record.