FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.— 510(k) K884427

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K884427 for FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT., Substantially Equivalent on 1988-11-02. Applicant: Bivona Medical Technologies.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1988-10-20
Decision date: 1988-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, 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.