510(k) K963074

HARMAC QUADPOLAR MAPPING PACING CATHETER by Harmac Medical Products, Inc. — Product Code DRF

K963074 is an FDA 510(k) premarket notification submitted by Harmac Medical Products, Inc. for the device "HARMAC QUADPOLAR MAPPING PACING CATHETER". The FDA issued a decision of Substantially Equivalent on June 25, 1997. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Harmac Medical Products, Inc. has at least 7 other 510(k) clearances on record.