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Tracheal Tube W/Airway Intubator

by Sheridan Catheter Corp.

510(k) K844746

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844746 Date14 Jan 1985ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTR
Device Class
Class II
Regulation
21 CFR Part 868.5730
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tracheal Tube W/Airway Intubator is a medical device classified as a tracheal tube with or without connector, intended for use in airway intubation procedures. It is designed to maintain an open airway during anesthesia or respiratory support, facilitating ventilation and oxygenation of patients.

This device is supplied as a Class II medical device under product code BTR, with FDA 510(k) clearance K844746 obtained on January 14, 1985. It is regulated under number 868.5730 and is intended for use in anesthesiology. The device is manufactured by Sheridan Catheter Corp. and is available in various sizes as indicated by the multiple registration numbers associated with this product.

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Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Tracheal Tube W/Airway Intubator used for?

    It is used to maintain an open airway during anesthesia or respiratory support, facilitating ventilation and oxygenation of patients.

  • Is the Tracheal Tube W/Airway Intubator supplied sterile?

    The device data does not specify sterility, but it is intended for use in medical procedures and should be handled accordingly.

  • What sizes are available for the Tracheal Tube W/Airway Intubator?

    The device is available in various sizes, as indicated by the multiple registration numbers associated with this product.

  • How is the Tracheal Tube W/Airway Intubator regulated?

    It is regulated under number 868.5730 and is classified as a Class II medical device under product code BTR.