ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))— 510(k) K121028

Substantially Equivalent

Etview , Ltd.

FDA 510(k) clearance K121028 for ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)), Substantially Equivalent on 2012-06-21. Applicant: Etview , Ltd..

Clearance details

Applicant: Etview , Ltd.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2012-04-05
Decision date: 2012-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

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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.