Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits

No FDA recalls found in the data synced 12 Oct 2026.

510(k) Number

K051711 ↗

FDA Product Code

PNG

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 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

• Denver Pleural Effusion Shunt With External Pump Chamber

  Class II

  FDA 510(k) K011020 Active Cleared 1 Jun 2001

See all devices from Denver Biomedicals, Inc. →