NEPHROSTOMY GUIDEWIRE SHEATH— 510(k) K845047

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K845047 for NEPHROSTOMY GUIDEWIRE SHEATH, Substantially Equivalent on 1985-01-15. Applicant: American Edwards Laboratories.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code LJE
Advisory panel: Unknown
Date received: 1984-12-31
Decision date: 1985-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, 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.