510(k) K241581

Hemodialysis Catheter by Haolang Medical USA Corporation — Product Code MSD

K241581 is an FDA 510(k) premarket notification submitted by Haolang Medical USA Corporation for the device "Hemodialysis Catheter". The FDA issued a decision of Substantially Equivalent (kit) on May 16, 2025. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Haolang Medical USA Corporation has at least 2 other 510(k) clearances on record.