RUSCH ENDOBRONCHIAL TUBES— 510(k) K141888

Substantially Equivalent

Teleflexmedical, Inc.

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

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code CBI
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 ↗

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.