Cuffed Tracheal Tube (Multiple)

• • Ongoing Z-1318-2023 FDA Class II ·initiated 10 Feb 2023

  Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.

510(k) Number

K871204 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Foam Nose

  Class I

  FDA 510(k) K840399 Active Cleared 16 Mar 1984

• Isotonic Diluent

  Class I

  FDA 510(k) K781008 Active Cleared 28 Jun 1978

• Hi-Lo Temp Thermocouple to Thermister Adaptor

  Class II

  FDA 510(k) K844201 Active Cleared 4 Mar 1985

• Glucose Reagent (O-Toluidine)

  Class II

  FDA 510(k) K771314 Active Cleared 3 Aug 1977

• Ria Quant C-Peptide Kit

  Class I

  FDA 510(k) K812689 Active Cleared 6 Oct 1981

• Hi-Lo Temp(R) Model 8700 Patient Temp Monitor

  Class II

  FDA 510(k) K874568 Active Cleared 6 Jan 1988

See all devices from Mallinckrodt Critical Care →