DeviceClearance

Product code MPB— Gastroenterology, Urology

Zenysis Short-Term Dialysis Catheter

Classification name
Catheter, Hemodialysis, Non-Implanted
Device class
Class 2
Regulation
21 CFR 876.5540
Advisory panel
Gastroenterology, Urology
Total cleared
38
First cleared
Most recent

Market context for product code MPB

FDA has cleared 38 devices under product code MPB between 1987 and 2025, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MPB

Adverse events under product code MPB

product code MPB
Death
18
Malfunction
1,042
Total
1,060

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MPB

Data sourced from openFDA. This site is unofficial and independent of the FDA.