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

Name: FDA 510(k) clearance K141965
Creator: U.S. Food and Drug Administration
Published: 2015-07-02

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. 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: 2014-07-21
Decision date: 2015-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWM

view all

K212696 — Aspira Pleural Drainage System2023-03-03
K210509 — Rocket Platinum Cured Cathter2021-09-09
K201404 — Passio Pump Drainage System2020-11-20
K190292 — Passio Pump Drainage System2019-07-25
K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit2017-08-17

More clearances from Care Fusion

view all

K233021 — BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device2024-03-06
K231888 — BD Texium Needle-Free Syringe2023-09-25
K221319 — BD Alaris Pump Epidural Infusion Set2023-07-21
K221327 — BD Alaris Pump Infusion Sets2023-07-21
K223101 — BD Secondary Infusion Set2023-05-12

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.