ENDOBRONCHIAL TWIN LUMEN TUBE— 510(k) K834565

Substantially Equivalent

Portex, Inc.

FDA 510(k) clearance K834565 for ENDOBRONCHIAL TWIN LUMEN TUBE, Substantially Equivalent on 1984-01-17. Applicant: Portex, Inc..

Clearance details

Applicant: Portex, Inc.
Product code: Code BTS
Advisory panel: Anesthesiology
Date received: 1983-12-28
Decision date: 1984-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BTS

product code BTS

Death: 2
Malfunction: 877
Total: 879

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.