Rae II Tracheal Tube
510(k) K932280
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932280 | Date8 Jul 1993 | 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- Withdrawn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
- Full name
- Rae(R) II Tracheal Tube
- 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, 25 Sep 2026
The Rae II Tracheal Tube is a tracheal tube, which is a type of medical device used in anesthesiology. It is designed to be inserted into a patient's trachea to facilitate breathing during medical procedures. The device is made by Mallinckrodt Medical.
The Rae II Tracheal Tube is supplied with FDA 510(k) clearance, indicated by the regulation number 868.5730 and product code BTR. The device has a specific design and material composition, and its use is subject to certain guidelines and precautions to ensure safe and effective use. The tube is available in various sizes, but specific size information is not provided in the available data.
Other devices from Mallinckrodt Medical
Questions
AI-generated answers, 25 Sep 2026
What is the Rae II Tracheal Tube used for?
The Rae II Tracheal Tube is used to facilitate breathing during medical procedures, specifically in anesthesiology.
Is the Rae II Tracheal Tube supplied sterile?
The data does not specify if the Rae II Tracheal Tube is supplied sterile, it is recommended to follow proper sterilization procedures before use.
What sizes is the Rae II Tracheal Tube available in?
The available data does not provide specific size information for the Rae II Tracheal Tube, it is recommended to consult the manufacturer for size options.