Tracheal/Bronchial Differential Ventilation Tube

• • Terminated Z-0703-2020 FDA Class II ·initiated 30 Oct 2019

  The tracheal and brochial swivel connectors are incorrectly labeled.

• • Terminated Z-2368-2015 FDA Class I ·initiated 1 Jun 2015

  The double swivel connector may crack or separate on the endobronchial tube.

• 2 recalls, same reason

  • Terminated Z-0680-05 FDA Unclassified (pre-2012) ·initiated 23 Feb 2005
  • Terminated Z-0681-05 FDA Unclassified (pre-2012) ·initiated 23 Feb 2005

  The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-16137 stating 'Bronchial - Left' instead of 'Bronchial - Right'.

510(k) Number

K851856 ↗

FDA Product Code

CBI

Device Class

Class II

Regulation

21 CFR Part 868.5740

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Endotracheal Tube, Accessory

  Class II

  FDA 510(k) K862347 Active Cleared 11 Jul 1986

• 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

• Kim Naso-Intestinal Tube

  Class II

  FDA 510(k) K882918 Active Cleared 5 Dec 1988

See all devices from Sheridan Catheter Corp. →

• What is the Tracheal/Bronchial Differential Ventilation Tube used for?

  This tube is designed for use in anesthesiology to facilitate differential ventilation procedures, allowing for separate ventilation of the lungs when needed during medical procedures.

• Is this device single-use or reusable?

  The device description does not specify whether it is intended for single-use or reusable applications. Users should consult the manufacturer's instructions for specific guidance on reuse or disposal.

• What is the regulatory status of this device?

  The Tracheal/Bronchial Differential Ventilation Tube is classified as Class II with special controls under regulation number 868.5740. It received FDA 510(k) clearance with number K851856 on May 23, 1985, as substantially equivalent.

• What sizes and models of this tube are available?

  The device data does not provide specific information about available sizes or models. Users should contact Sheridan Catheter Corp. directly for detailed specifications regarding available options.