DeviceClearance

Product code MSD— Gastroenterology, Urology

VAXCEL PLUS CHRONIC DIALYSIS CATHETER

Classification name
Catheter, Hemodialysis, Implanted
Device class
Class 2
Regulation
21 CFR 876.5540
Advisory panel
Gastroenterology, Urology
Total cleared
124
First cleared
Most recent

Market context for product code MSD

FDA has cleared 124 devices under product code MSD between 1998 and 2025, filed by 44 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 MSD

Adverse events under product code MSD

product code MSD
Death
67
Injury
545
Malfunction
3,661
Total
4,273

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 MSD

1–100 of 124

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