510(k) K933451

OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION by Electro-Catheter Corp. — Product Code DRF

K933451 is an FDA 510(k) premarket notification submitted by Electro-Catheter Corp. for the device "OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION". The FDA issued a decision of Substantially Equivalent on April 19, 1995. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Electro-Catheter Corp. has at least 10 other 510(k) clearances on record.