510(k) K212708

Halo One Thin-Walled Guiding Sheath by C.R. Bard, Inc. — Product Code DYB

K212708 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Halo One Thin-Walled Guiding Sheath". The FDA issued a decision of Substantially Equivalent on September 23, 2021. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.