Laser Resistant Tracheal Tube

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K897046 ↗

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

• Tracheal/Bronchial Differential Ventilation Tube

  Class II

  FDA 510(k) K851856 Active Cleared 23 May 1985

See all devices from Sheridan Catheter Corp. →

• What is the primary clinical use for the Laser Resistant Tracheal Tube?

  This device is a tracheal or bronchial differential ventilation tube designed specifically to isolate either the left or right lung of a patient. It is intended for use during anesthesia or pulmonary function testing.

• What is the regulatory status of this device?

  The Laser Resistant Tracheal Tube manufactured by Sheridan Catheter Corp. has received FDA 510(k) clearance under the number K897046, having been determined to be substantially equivalent to predicate devices.

• Which medical specialty is this device associated with?

  This device is categorized under the Anesthesiology medical specialty, as it is designed for airway management and ventilation procedures during clinical care.