510(k) K233900

Nordica PV Cryo Mapping Catheter by Synaptic Medical Corporation — Product Code DRF

K233900 is an FDA 510(k) premarket notification submitted by Synaptic Medical Corporation for the device "Nordica PV Cryo Mapping Catheter". The FDA issued a decision of Substantially Equivalent on September 6, 2024. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Synaptic Medical Corporation has at least 3 other 510(k) clearances on record.