510(k) K823382— NEPHROSTOMY CATHETER

Substantially Equivalent

Umi, Inc.

Clearance details

Applicant: Umi, Inc.
Product code: Code LJE
Advisory panel: Unknown
Date received: 1982-11-12
Decision date: 1983-01-28
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.