510(k) K100451

GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 by Gambro Renal Products, Inc. — Product Code MPB

K100451 is an FDA 510(k) premarket notification submitted by Gambro Renal Products, Inc. for the device "GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132". The FDA issued a decision of Substantially Equivalent on December 21, 2010. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Gambro Renal Products, Inc. has at least 10 other 510(k) clearances on record.