Endotracheal Tube, Accessory

• • Terminated Z-0129-2007 FDA Unclassified (pre-2012) ·initiated 27 Sep 2006 ·on shared 510(k) K862347

  Biological indicator failed. Investigation eliminated all equipment and product related factors.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K862347 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Lazer-Trach Tracheal Tube

  Class II

  FDA 510(k) K922894 Active Cleared 7 May 1993

• Introduction/Drainage Catheter & Access

  Class I

  FDA 510(k) K881873 Active Cleared 18 May 1988

• Clinical Electronic Thermometers

  Class II

  FDA 510(k) K882127 Active Cleared 4 Aug 1988

• Ndyag Laser Tracheal Tube

  Class II

  FDA 510(k) K880960 Active Cleared 29 Apr 1988

• Tracheal/Bronchial Differential Ventilation Tube

  Class II

  FDA 510(k) K851856 Active Cleared 23 May 1985

• Kim Naso-Intestinal Tube

  Class II

  FDA 510(k) K882918 Active Cleared 5 Dec 1988

See all devices from Sheridan Catheter Corp. →