BIVONA ENDOTRACHEAL TUBE STYLET— 510(k) K905052

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K905052 for BIVONA ENDOTRACHEAL TUBE STYLET, Substantially Equivalent on 1991-04-02. Applicant: Bivona Medical Technologies.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code BSR
Advisory panel: Anesthesiology
Date received: 1990-11-08
Decision date: 1991-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

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Adverse events under product code BSR

product code BSR

Death: 2
Other: 1
Total: 3

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.