510(k) K261492

FieldFlex Steerable Sheath by CenterPoint Systems, LLC — Product Code DYB

K261492 is an FDA 510(k) premarket notification submitted by CenterPoint Systems, LLC for the device "FieldFlex Steerable Sheath". The FDA issued a decision of Substantially Equivalent on June 5, 2026. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. CenterPoint Systems, LLC has at least 10 other 510(k) clearances on record.