About This 510(k) Submission
K202176 is an FDA 510(k) clearance for the Symetrex LTHD Catheter, Symetrex LTHD 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 September 3, 2020, 30 days after receiving the submission on August 4, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.