510(k) K974335

EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. by J-Lloyd Medical, Inc. — Product Code DXE

K974335 is an FDA 510(k) premarket notification submitted by J-Lloyd Medical, Inc. for the device "EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.". The FDA issued a decision of Substantially Equivalent on February 13, 1998. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. J-Lloyd Medical, Inc. has at least 10 other 510(k) clearances on record.