Pleural Catheter and Drainage Kits

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

Full name

Pleurx Pleural Catheter and Drainage Kits

510(k) Number

K010642 ↗

FDA Product Code

DWM

Device Class

Class II

Regulation

21 CFR Part 870.5050

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits

  Class II

  FDA 510(k) K051711 Active Cleared 15 Nov 2005

• Crouch Corneal Protector

  Class I

  FDA 510(k) K811577 Active Cleared 7 Aug 1981

• Denver Peritoneo-Venous Shunt (DP-VS)

  Class II

  FDA 510(k) K822686 Active Cleared 21 Sep 1982

• Denver Pleural Effusion Shunt and Denver Pleural Effusion Shunt with External Pump Chamber

  Class II

  FDA 510(k) K012235 Active Cleared 4 Oct 2001

• Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage Line

  Class II

  FDA 510(k) K051084 Active Cleared 13 Jun 2005

• Denver Pak W/ Double-Valve Ascites Shunt, Denver Pak W/ Single-Valved Ascites Shunt, Denver Pak, Doubled-Valved Ascites T

  Class II

  FDA 510(k) K003451 Active Cleared 2 Jan 2001

See all devices from Denver Biomedicals, Inc. →

• What is the PleurX pleural catheter and drainage kit used for?

  The PleurX pleural catheter and drainage kit is designed for the management of pleural effusions and malignant ascites, allowing drainage of excess fluid from the pleural space in both clinical and home settings.

• Is the PleurX pleural catheter and drainage kit reusable or single-use?

  The PleurX pleural catheter and drainage kit is a single-use system, meaning it is intended for one-time use only and should not be reprocessed or reused after initial deployment.

• How is the PleurX pleural catheter and drainage kit supplied?

  The device is supplied as a complete drainage kit, including the flexible and soft pleural catheter and associated components necessary for insertion and fluid drainage in patient care.