FDA Product Code MSD: Catheter, Hemodialysis, Implanted
Leading manufacturers include C.R. Bard, Inc., Bard Peripheral Vascular, Inc. and Haolang Medical USA Corporation.
FDA 510(k) Cleared Catheter, Hemodialysis, Implanted Devices (Product Code MSD)
About Product Code MSD - Regulatory Context
510(k) Submission Activity
124 total 510(k) submissions under product code MSD since 1998, with 124 receiving FDA clearance (average review time: 139 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MSD have taken an average of 347 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.
MSD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →