Tracheal Tube W/Airway Intubator
510(k) K844746
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844746 | Date14 Jan 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Sheridan Catheter Corp.
Questions
AI-generated answers, 28 Sep 2026
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.