510(k) K260929

Neonav ECG Tip Location System by Navi Medical Technologies — Product Code LJS

K260929 is an FDA 510(k) premarket notification submitted by Navi Medical Technologies for the device "Neonav ECG Tip Location System". The FDA issued a decision of Substantially Equivalent on April 17, 2026. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Navi Medical Technologies has at least 1 other 510(k) clearance on record.