RUSCH ENDOBRONCHIAL TUBES— 510(k) K141888

Name: FDA 510(k) clearance K141888
Creator: U.S. Food and Drug Administration
Published: 2015-04-15

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K141888 for RUSCH ENDOBRONCHIAL TUBES, Substantially Equivalent on 2015-04-15. Applicant: Teleflexmedical, Inc.. Device class: 2.

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code CBI
Device class: Class 2
Regulation: 21 CFR 868.5740
Advisory panel: Anesthesiology
Date received: 2014-07-14
Decision date: 2015-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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K182847 — Hudson RCI Voldyne Volumetric Exerciser2019-07-01
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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.