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

Substantially Equivalent

Care Fusion

Clearance details

Applicant: Care Fusion
Product code: Code DWM
Advisory panel: Cardiovascular
Date received: 2012-06-25
Decision date: 2012-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, US

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.