510(k) K030268

NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS by C.R. Bard, Inc. — Product Code MPB

K030268 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS". The FDA issued a decision of Substantially Equivalent on July 30, 2003. 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.