NEPHROSTOMY/BILIARY DRAINAGE BAG— 510(k) K834476

Substantially Equivalent

Vertex Medical Corp.

FDA 510(k) clearance K834476 for NEPHROSTOMY/BILIARY DRAINAGE BAG, Substantially Equivalent on 1984-02-04. Applicant: Vertex Medical Corp..

Clearance details

Applicant: Vertex Medical Corp.
Product code: 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

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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.