Rusch Reinforced Endotracheal (or Tracheal) Tube- Cuffed and Uncuffed Murphy/Magill, Sterile

• • Terminated Z-1124-2015 FDA Class II ·initiated 12 Dec 2014

  Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff diameter. The actual product cuff diameter meets required specification.

510(k) Number

K990619 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Epidural Catheter Models 1210/1200

  Class II

  FDA 510(k) K983125 Active Cleared 17 Nov 1998

• Flocath

  Class II

  FDA 510(k) K000070 Active Cleared 18 Feb 2000

• Intermittent Urethral Catheters

  Class II

  FDA 510(k) K033023 Active Cleared 23 Dec 2003

• Rusch Miller-Abbott Tube

  Class II

  FDA 510(k) K010797 Active Cleared 26 Feb 2002

• Rusch Floneil; Flocath Introgel

  Class II

  FDA 510(k) K020714 Active Cleared 1 Jul 2002

• Rusch Schroeder Endotracheal Tube Style

  Class I

  FDA 510(k) K955238 Active Cleared 6 Feb 1996

See all devices from Rusch Intl. →