FDA Product Code MPB: Catheter, Hemodialysis, Non-implanted
Leading manufacturers include Medical Components, Inc..
FDA 510(k) Cleared Catheter, Hemodialysis, Non-implanted Devices (Product Code MPB)
About Product Code MPB - Regulatory Context
510(k) Submission Activity
38 total 510(k) submissions under product code MPB since 1987, with 38 receiving FDA clearance (average review time: 225 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 MPB have taken an average of 145 days to reach a decision - down from 227 days historically, suggesting improved FDA processing for this classification.
MPB devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →