510(k) K130851

CASCADE HEMODIALYSIS/APHERESIS CATHETER by Health Line International Corporation — Product Code MSD

K130851 is an FDA 510(k) premarket notification submitted by Health Line International Corporation for the device "CASCADE HEMODIALYSIS/APHERESIS CATHETER". The FDA issued a decision of Substantially Equivalent (kit) on January 9, 2014. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Health Line International Corporation has at least 10 other 510(k) clearances on record.