COOPDECH ENDOBRONCHIAL BLOCKER TUBE— 510(k) K093888

Substantially Equivalent

Daiken Medical Co, Ltd.

FDA 510(k) clearance K093888 for COOPDECH ENDOBRONCHIAL BLOCKER TUBE, Substantially Equivalent on 2010-03-16. Applicant: Daiken Medical Co, Ltd..

Clearance details

Applicant: Daiken Medical Co, Ltd.
Product code: Code CBI
Advisory panel: Anesthesiology
Date received: 2009-12-18
Decision date: 2010-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

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Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

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.