Denver Pleural Effusion Shunt With External Pump Chamber

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K011020 ↗

FDA Product Code

KPM

Device Class

Class II

Regulation

21 CFR Part 876.5955

Advisory Committee

Gastroenterology, Urology

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 Denver Pleural Effusion Shunt with External Pump Chamber used for?

  The Denver Pleural Effusion Shunt with external pump chamber is a peritoneo-venous shunt device used to palliate symptoms of recurrent pleural effusion, which is an accumulation of fluid in the cavity around the lungs. It helps drain fluid from the pleural cavity into the venous system.

• How is the Denver Pleural Effusion Shunt supplied and is it reusable?

  The Denver Pleural Effusion Shunt is supplied as a single-use device and requires appropriate storage conditions. It is not designed for reuse and should be discarded after a single use to ensure patient safety and device effectiveness.

• What is the regulatory status of the Denver Pleural Effusion Shunt?

  The Denver Pleural Effusion Shunt has FDA 510(k) clearance with product code KPM and is classified under device class 2. This means it has been determined to be substantially equivalent to other legally marketed devices of the same type.

• How is the Denver Pleural Effusion Shunt implanted?

  The device is implanted with one end positioned in the pleural cavity and the other end in a large vein. It consists of a catheter and a pressure-activated one-way valve that enables fluid to flow from the pleural cavity into the venous system, helping to alleviate symptoms of pleural effusion.