510(k) K802481

7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH by Waters Assoc., Inc. — Product Code DYG

K802481 is an FDA 510(k) premarket notification submitted by Waters Assoc., Inc. for the device "7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Waters Assoc., Inc. has at least 10 other 510(k) clearances on record.