PEDIA-TRAKE CRICOTHYROTOMY KIT— 510(k) K840925

Substantially Equivalent

Intl. Medical Devices , Ltd.

FDA 510(k) clearance K840925 for PEDIA-TRAKE CRICOTHYROTOMY KIT, Substantially Equivalent on 1984-05-02. Applicant: Intl. Medical Devices , Ltd..

Clearance details

Applicant: Intl. Medical Devices , Ltd.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1984-03-02
Decision date: 1984-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroeville, PA, US

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Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.