TRACHEOSTOMY CARE KIT— 510(k) K941470

Unknown

Clinical Resources, Inc.

FDA 510(k) clearance K941470 for TRACHEOSTOMY CARE KIT, Unknown on 1995-02-14. Applicant: Clinical Resources, Inc..

Clearance details

Applicant: Clinical Resources, Inc.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1994-03-28
Decision date: 1995-02-14
Decision: Unknown
Clearance type: Traditional
Location: Elgin, IL, 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.