510(k) K261950

Health Line Tearaway Introducer by Health Line International Corporation — Product Code DYB

K261950 is an FDA 510(k) premarket notification submitted by Health Line International Corporation for the device "Health Line Tearaway Introducer". The FDA issued a decision of Substantially Equivalent on June 22, 2026. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Health Line International Corporation has at least 10 other 510(k) clearances on record.