510(k) K252027

Vertex(TM) Catheter by Jupiter Endovascular — Product Code DYB

K252027 is an FDA 510(k) premarket notification submitted by Jupiter Endovascular for the device "Vertex(TM) Catheter". The FDA issued a decision of Substantially Equivalent on September 12, 2025. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Jupiter Endovascular has at least 1 other 510(k) clearance on record.