510(k) K950440

DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD by J-Lloyd Medical, Inc. — Product Code DQO

K950440 is an FDA 510(k) premarket notification submitted by J-Lloyd Medical, Inc. for the device "DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. J-Lloyd Medical, Inc. has at least 10 other 510(k) clearances on record.