BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)— 510(k) K111406

Substantially Equivalent

Hangzhou Bever Medical Devices Co., Ltd.

FDA 510(k) clearance K111406 for BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL), Substantially Equivalent on 2012-07-19. Applicant: Hangzhou Bever Medical Devices Co., Ltd..

Clearance details

Applicant: Hangzhou Bever Medical Devices Co., Ltd.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2011-05-19
Decision date: 2012-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, Zhejiang, CN

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.