510(k) K012562

MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER by Medical Components, Inc. — Product Code MSD

K012562 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent on February 8, 2002. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Medical Components, Inc. has at least 10 other 510(k) clearances on record.