NU-CATH EMERGENCY KIT— 510(k) K850398

Substantially Equivalent

Intl. Medical Devices , Ltd.

FDA 510(k) clearance K850398 for NU-CATH EMERGENCY KIT, Substantially Equivalent on 1985-03-27. Applicant: Intl. Medical Devices , Ltd..

Clearance details

Applicant: Intl. Medical Devices , Ltd.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 1985-02-01
Decision date: 1985-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.