510(k) K040301

GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A by Gambro Renal Products — Product Code MPB

K040301 is an FDA 510(k) premarket notification submitted by Gambro Renal Products for the device "GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A". The FDA issued a decision of Substantially Equivalent (kit) on November 1, 2004. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Gambro Renal Products has at least 10 other 510(k) clearances on record.