510(k) K233708

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) by Synaptic Medical Corporation — Product Code DYB

K233708 is an FDA 510(k) premarket notification submitted by Synaptic Medical Corporation for the device "NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)". The FDA issued a decision of Substantially Equivalent on February 16, 2024. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Synaptic Medical Corporation has at least 3 other 510(k) clearances on record.