510(k) K030983

TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY by Deltec, Inc. — Product Code MSD

K030983 is an FDA 510(k) premarket notification submitted by Deltec, Inc. for the device "TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY". The FDA issued a decision of Substantially Equivalent (kit) on April 25, 2003. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Deltec, Inc. has at least 4 other 510(k) clearances on record.