Argyle Jet Tracheal Tube
510(k) K833807
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833807 | Date13 Jan 1984 | 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- Withdrawn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, 6 Oct 2026
The Argyle Jet Tracheal Tube is a Class 2 medical device used in anesthesiology procedures. It is designed for tracheal intubation and functions as a jet tube for airway management during surgical or emergency situations.
The device is manufactured by Sherwood Medical Co. and is supplied in various sizes as indicated by the multiple registration numbers. It received FDA 510(k) clearance on January 13, 1984, with product code BTR, and is regulated under 868.5730. The device is not specified as single-use or reusable in the provided data.
Other devices from Sherwood Medical Co.
Questions
AI-generated answers, 6 Oct 2026
What is the Argyle Jet Tracheal Tube used for?
The Argyle Jet Tracheal Tube is a Class 2 medical device designed for tracheal intubation and functions as a jet tube for airway management during surgical or emergency situations in anesthesiology procedures.
Is the Argyle Jet Tracheal Tube single-use or reusable?
The provided data does not specify whether the Argyle Jet Tracheal Tube is designed for single-use or reusable purposes. Clinicians should consult the manufacturer's instructions for use to determine the appropriate handling protocol.
What sizes are available for the Argyle Jet Tracheal Tube?
The Argyle Jet Tracheal Tube is supplied in various sizes as indicated by the multiple registration numbers provided in the device data. The specific size options should be confirmed with the manufacturer or product documentation.
What is the regulatory status of the Argyle Jet Tracheal Tube?
The Argyle Jet Tracheal Tube received FDA 510(k) clearance on January 13, 1984, with product code BTR, and is regulated under 868.5730. It is classified as a Class 2 medical device and was determined to be substantially equivalent to predicate devices.