510(k) K861165

PHARMASEAL DUAL LUMEN CATHETER by American Pharmaseal Div. Ahsc — Product Code DQY

K861165 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "PHARMASEAL DUAL LUMEN CATHETER". The FDA issued a decision of Substantially Equivalent on May 5, 1986. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.