510(k) K133028

RITHM ID ELECTROPHYSIOLOGY CATHETER by Synaptic Medical Limited — Product Code DRF

K133028 is an FDA 510(k) premarket notification submitted by Synaptic Medical Limited for the device "RITHM ID ELECTROPHYSIOLOGY CATHETER". The FDA issued a decision of Substantially Equivalent on March 4, 2014. 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 Limited has at least 2 other 510(k) clearances on record.