About This 510(k) Submission
K173667 is an FDA 510(k) clearance for the 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, a Catheter, Hemodialysis, Implanted (Class II — Special Controls, product code MSD), submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on May 17, 2018, 168 days after receiving the submission on November 30, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.