K834476

Substantially Equivalent

NEPHROSTOMY/BILIARY DRAINAGE BAG

Applicant: Vertex Medical Corp.
Product code: LJE
Advisory panel: Unknown
Date received: 1983-12-20
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code LJE

product code LJE

Death: 6
Total: 6

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.