5.0 Fr Arndt Endobronchial Blocker Set— 510(k) K160542

Name: FDA 510(k) clearance K160542
Creator: U.S. Food and Drug Administration
Published: 2016-08-02

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K160542 for 5.0 Fr Arndt Endobronchial Blocker Set, Substantially Equivalent on 2016-08-02. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code CBI
Device class: Class 2
Regulation: 21 CFR 868.5740
Advisory panel: Anesthesiology
Date received: 2016-02-26
Decision date: 2016-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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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.