510(k) K190527

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters by C. R. Bard — Product Code MSD

K190527 is an FDA 510(k) premarket notification submitted by C. R. Bard for the device "GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters". The FDA issued a decision of Substantially Equivalent (kit) on March 5, 2020. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. C. R. Bard has at least 8 other 510(k) clearances on record.