K110793

Substantially Equivalent

AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS

Applicant: Ameco Medical Industries
Product code: MPB
Advisory panel: Gastroenterology, Urology
Date received: 2011-03-22
Decision date: 2011-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mason, NH, US

Adverse events under product code MPB

product code MPB

Death: 18
Malfunction: 1,042
Total: 1,060

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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