510(k) K021421

PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE by Tz Medical, Inc. — Product Code DRF

K021421 is an FDA 510(k) premarket notification submitted by Tz Medical, Inc. for the device "PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE". The FDA issued a decision of Substantially Equivalent on April 18, 2003. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Tz Medical, Inc. has at least 10 other 510(k) clearances on record.