510(k) K242106

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

K242106 is an FDA 510(k) premarket notification submitted by CenterPoint Systems, LLC for the device "AuST Steerable Sheath". The FDA issued a decision of Substantially Equivalent on October 4, 2024. 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.