510(k) K241587

pilot TLS by Vygon Corporation — Product Code LJS

K241587 is an FDA 510(k) premarket notification submitted by Vygon Corporation for the device "pilot TLS". The FDA issued a decision of Substantially Equivalent on February 26, 2025. 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.