510(k) K963335

HARMAC BALLOON WEDGE PRESSURE CATHETER by Harmac Medical Products, Inc. — Product Code DQO

K963335 is an FDA 510(k) premarket notification submitted by Harmac Medical Products, Inc. for the device "HARMAC BALLOON WEDGE PRESSURE CATHETER". The FDA issued a decision of Substantially Equivalent on October 16, 1997. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Harmac Medical Products, Inc. has at least 7 other 510(k) clearances on record.