Denver Pleurx Pleural Catheter Kit, Catalog No. 50-7000, Denver Pleurx Home Drainage Kit, Catalog No. 50-7500

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

510(k) Number

K971753 ↗

FDA Product Code

DWM

Device Class

Class II

Regulation

21 CFR Part 870.5050

Advisory Committee

Cardiovascular

FDA Decision

SESK Substantially Equivalent — Kit

• Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access Kits

  Class II

  FDA 510(k) K973129 Active Cleared 17 Mar 1998

• Denver Paracentesis Needle(60-1200) Denver Paracentesis Needle with Drainage Line(60-1100) Denver Paracentesis Tray

  Class I

  FDA 510(k) K960456 Active Cleared 1 Apr 1996

• Denver Pleural Effusion Shunt with External Pump Chamber

  Class II

  FDA 510(k) K962814 Active Cleared 14 Apr 1997

• What is the Denver Pleurx system used for?

  The Denver Pleurx system is a sterile, single-use device for the intermittent, long-term drainage of symptomatic, recurrent malignant pleural effusion. It is indicated for the palliation of dyspnea caused by this condition and for providing pleurodesis.

• Is the Denver Pleurx catheter kit for single use?

  Yes, the Denver Pleurx Pleural Catheter Kit and Denver Pleurx Home Drainage Kit are supplied as sterile, single-use systems. They are intended for one-time use on a single patient.

• How is the device classified and regulated?

  The device is classified as a Class II medical device under the U.S. FDA's Special Controls framework. It has received FDA 510(k) clearance (K971753) for marketing in the United States.

• What is the regulatory submission type for this device?

  The Denver Pleurx catheter kit was submitted under the Traditional 510(k) clearance pathway. This regulatory route requires the manufacturer to demonstrate that the device is substantially equivalent to a legally marketed predicate device.