510(k) K971504

HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER by J-Lloyd Medical, Inc. — Product Code DRF

K971504 is an FDA 510(k) premarket notification submitted by J-Lloyd Medical, Inc. for the device "HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER". The FDA issued a decision of Substantially Equivalent on April 20, 1998. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. J-Lloyd Medical, Inc. has at least 10 other 510(k) clearances on record.