510(k) K022905

LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER by Horizon Medical Products, Inc. — Product Code MSD

K022905 is an FDA 510(k) premarket notification submitted by Horizon Medical Products, Inc. for the device "LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER". The FDA issued a decision of Substantially Equivalent on Dec 13, 2002. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Horizon Medical Products, Inc. has 15 other 510(k) clearances on record.