Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K122422 ↗

FDA Product Code

PNG

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESK Substantially Equivalent — Kit

• BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device

  Class II

  FDA 510(k) K233021 Active Cleared 6 Mar 2024

• Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee

  Class II

  FDA 510(k) K121849 Active Cleared 18 Oct 2012

• PleurX Peritoneal Catheter System

  Class II

  FDA 510(k) K201155 Active Cleared 21 Oct 2020

• End Tidal CO2 Nasal Cannula

  Class II

  FDA 510(k) K120518 Active Cleared 4 May 2012

• AirLife Infant Heated Wire Circuit Open recall

  Class II

  FDA 510(k) K151303 Active Cleared 21 Jan 2016

• BD Secondary Infusion Set

  Class II

  FDA 510(k) K223101 Active Cleared 12 May 2023

See all devices from Carefusion →