Hood Pediatric Tracheostomy Tube

• • Terminated Z-1667-2013 FDA Class I ·initiated 17 Apr 2013

  The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

510(k) Number

K893866 ↗

FDA Product Code

BTO

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Hood Speaking Valve

  Class II

  FDA 510(k) K897059 Active Cleared 12 Mar 1990

• Hood Nasal Septal Button

  Unclassified

  FDA 510(k) K920994 Active Cleared 15 May 1992

• The Hood Life Saver

  Class II

  FDA 510(k) K853511 Active Cleared 19 Dec 1985

• Eliachar Modified Esophageal Stent

  Class II

  FDA 510(k) K904821 Active Cleared 14 Jan 1991

• Hood Esophageal Prosthesis

  Class II

  FDA 510(k) K871244 Active Cleared 13 Apr 1987

• Acoustic Rhinometer

  Class II

  FDA 510(k) K921452 Active Cleared 8 Jul 1993

See all devices from Hood Laboratories →