PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE— 510(k) K121849

Name: FDA 510(k) clearance K121849
Creator: U.S. Food and Drug Administration
Published: 2012-10-18

Substantially Equivalent

Care Fusion

FDA 510(k) clearance K121849 for PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE, Substantially Equivalent on 2012-10-18. Applicant: Care Fusion. Device class: 2.

Clearance details

Applicant: Care Fusion
Product code: Code DWM
Device class: Class 2
Regulation: 21 CFR 870.5050
Advisory panel: Cardiovascular
Date received: 2012-06-25
Decision date: 2012-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, US

Download summary PDF View on FDA.gov ↗

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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.