510(k) K090102

NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS by C.R. Bard, Inc. — Product Code MPB

K090102 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on February 12, 2009. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.