BIVONA TRACHEOSTOMY TUBES— 510(k) K083641

Substantially Equivalent

Smiths Medical Asd, Inc.

FDA 510(k) clearance K083641 for BIVONA TRACHEOSTOMY TUBES, Substantially Equivalent on 2009-02-23. Applicant: Smiths Medical Asd, Inc..

Clearance details

Applicant: Smiths Medical Asd, Inc.
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 2008-12-09
Decision date: 2009-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

Download summary PDF View on FDA.gov ↗

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.