510(k) K051584

14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY by Kendall — Product Code MSD

K051584 is an FDA 510(k) premarket notification submitted by Kendall for the device "14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY". The FDA issued a decision of Substantially Equivalent on October 6, 2005. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Kendall has at least 10 other 510(k) clearances on record.