510(k) K243493

Agilis NxT Steerable Introducer Dual-Reach by ABBOTT MEDICAL — Product Code DYB

K243493 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Agilis NxT Steerable Introducer Dual-Reach". The FDA issued a decision of Substantially Equivalent on December 13, 2024. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.