Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula

• • Terminated Z-1732-2019 FDA Class II ·initiated 11 Feb 2019

  Packaged with an incorrect size inner cannula.

• • Terminated Z-0714-06 FDA Unclassified (pre-2012) ·initiated 7 Mar 2006

  Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm

510(k) Number

K030381 ↗

FDA Product Code

BTO

FDA applicant

Portex , Ltd.

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Trocar Catheter/Thoracic Catheter

  Class II

  FDA 510(k) K792202 Active Cleared 20 Nov 1979

• Thermovent 600, 1200, T, 02

  Class I

  FDA 510(k) K874597 Active Cleared 19 Jan 1988

• Blue Line Ultra Suctionaid Tracheostomy Tube

  Class II

  FDA 510(k) K030570 Active Cleared 17 Sep 2003

• Jet Ventilation Adaptor

  Not classified

  FDA 510(k) K842456 Active Cleared 6 Jul 1984

• 1ST Response Intermediate Manual Resuscitator

  Class II

  FDA 510(k) K023793 Active Cleared 11 Feb 2003

• Reinforced Silicone Tracheal Tube

  Class II

  FDA 510(k) K830352 Active Cleared 8 Mar 1983

See all devices from Portex, Ltd. →