510(k) K994105

HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 by Medical Components, Inc. — Product Code MSD

K994105 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40". The FDA issued a decision of Substantially Equivalent on October 3, 2001. 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.