510(k) K965178

NIAGARA DUAL LUMEN CATHETER by Vas-Cath, Inc. — Product Code MPB

K965178 is an FDA 510(k) premarket notification submitted by Vas-Cath, Inc. for the device "NIAGARA DUAL LUMEN CATHETER". The FDA issued a decision of Substantially Equivalent on August 19, 1997. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Vas-Cath, Inc. has at least 10 other 510(k) clearances on record.