About This 510(k) Submission
K190527 is an FDA 510(k) clearance for the GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters, a Catheter, Hemodialysis, Implanted (Class II — Special Controls, product code MSD), submitted by C. R. Bard (Salt Lake Ciy,, US). The FDA issued a Cleared decision on March 5, 2020, 367 days after receiving the submission on March 4, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.