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PleurX Pleural Catheter Systems

by Care Fusion

510(k) K112831

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK112831 Date16 Feb 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWM
Device Class
Class II
Regulation
21 CFR Part 870.5050
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PleurX Pleural Catheter System is a patient care suction apparatus designed for the intermittent, long-term drainage of symptomatic, recurrent pleural effusion. It consists of a fenestrated silicone catheter featuring a valve mechanism and a polyester cuff to facilitate effective drainage while preventing air or fluid leakage.

This device is indicated for the palliation of dyspnea due to pleural effusion and for providing pleurodesis. The system is supplied as a kit, which may include placement trays, starter kits, and drainage kits. It has received FDA 510(k) clearance under the regulation number 870.5050.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use of the PleurX Pleural Catheter System?

    This device is indicated for the palliation of dyspnea caused by pleural effusion and for providing pleurodesis. It is designed specifically for the intermittent, long-term drainage of symptomatic, recurrent pleural effusion.

  • How is the PleurX system supplied to clinicians?

    The system is supplied as a kit to facilitate clinical use. These kits may include placement trays, starter kits, and drainage kits to support the catheterization process.

  • What features help prevent leakage during drainage?

    The catheter includes a valve mechanism and a polyester cuff. These components are integrated into the fenestrated silicone design to facilitate effective drainage while preventing the leakage of air or fluid.

  • What is the regulatory status of this device?

    The PleurX Pleural Catheter System has received FDA 510(k) clearance under regulation number 870.5050. It was determined to be substantially equivalent to existing devices during the review process.