Shiley Flextra Tracheostomy Tube

• • Terminated Z-0721-05 FDA Unclassified (pre-2012) ·initiated 9 Dec 2004 ·on shared 510(k) K030787

  Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.

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

510(k) Number

K030787 ↗

FDA Product Code

JOH

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Nellcor Puritan Bennett, Inc. →