Denver Pleural Effusion Shunt with External Pump Chamber

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K962814 ↗

FDA Product Code

KPM

Device Class

Class II

Regulation

21 CFR Part 876.5955

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access Kits

  Class II

  FDA 510(k) K973129 Active Cleared 17 Mar 1998

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

  Class II

  FDA 510(k) K971753 Active Cleared 27 Jun 1997

• 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