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Pleurx Pleural Catheter System

by Care Fusion

510(k) K160450

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 NumberK160450 Date31 Oct 2016ClearedStatusActive

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  • Withdrawn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, 6 Oct 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 an apparatus for suction, patient care, designed for the intermittent, long-term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusions and other recurrent effusions that do not respond to medical management of the underlying disease. It is indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis, which is the resolution of the pleural effusion.

The device is supplied as part of a comprehensive portfolio that includes placement trays, starter kits, drainage kits, and accessories. It is intended for single-use applications and must be used in accordance with the provided instructions for use. The device is regulated under the U.S. Food and Drug Administration's 510(k) program, with a decision of substantially equivalent to a predicate device.

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Questions

AI-generated answers, 6 Oct 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 Pleurx Pleural Catheter System used for?

    It is designed for the intermittent, long-term drainage of symptomatic, recurrent pleural effusions, including malignant pleural effusions and other recurrent effusions that do not respond to medical management of the underlying disease.

  • Is the Pleurx catheter intended for single use?

    Yes, the device is intended for single-use applications and must be used in accordance with the provided instructions for use.

  • How is the Pleurx system supplied?

    The device is supplied as part of a comprehensive portfolio that includes placement trays, starter kits, drainage kits, and accessories.

  • What is the regulatory status of the Pleurx Pleural Catheter System?

    The device is regulated under the U.S. Food and Drug Administration's 510(k) program, with a decision of substantially equivalent to a predicate device.