BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE— 510(k) K894614

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K894614 for BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE, Substantially Equivalent on 1989-10-13. Applicant: Bivona Medical Technologies.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 1989-07-20
Decision date: 1989-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

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Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

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.