PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT— 510(k) K141965

Substantially Equivalent

Care Fusion

FDA 510(k) clearance K141965 for PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, Substantially Equivalent on 2015-07-02. Applicant: Care Fusion.

Clearance details

Applicant: Care Fusion
Product code: Code DWM
Advisory panel: Cardiovascular
Date received: 2014-07-21
Decision date: 2015-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

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Adverse events under product code DWM

product code DWM

Death: 8
Total: 8

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.