Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with…
FDA 510(k)Class II (US FDA 510(k))
by Covidien llc
Identifiers
- 510(k) Number
- K251313 FDA 510(k)
- FDA Product Code
- JOH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5800 FDA 510(k)
- Regulation Number
- 868.5800 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Shiley Adult Flexible Tracheostomy Tube XLT is a sterile, single-use dual cannula tracheostomy tube with a 90° curve. It is available with or without a TaperGuard cuff and in extended length configurations for both proximal and distal portions to accommodate patients with challenging anatomies. The device includes a disposable inner cannula and is designed for adult patients requiring extra length support.
The Shiley Adult Flexible Tracheostomy Tube XLT is supplied as a sterile, single-use device and is not intended for reuse. It is available in various configurations including cuffed and cuffless options with extended proximal or distal lengths. The device has received FDA 510(k) clearance with the product code JOH and is classified under device class 2 for tracheostomy tubes and cuffs.
Frequently asked questions
What is the Shiley XLT Flexible Tracheostomy Tube used for?
The Shiley XLT Flexible Tracheostomy Tube is designed for adult patients requiring tracheostomy support, particularly those with challenging anatomies who need extended length configurations. It features a 90° curve and is available with or without a TaperGuard cuff to accommodate various clinical needs.
How is the Shiley XLT Tracheostomy Tube supplied and is it reusable?
The Shiley XLT Tracheostomy Tube is supplied as a sterile, single-use device and is not intended for reuse. It comes with a disposable inner cannula and is available in multiple configurations including cuffed and cuffless options with extended proximal or distal lengths.
What regulatory status does the Shiley XLT Tracheostomy Tube have?
The Shiley XLT Tracheostomy Tube has received FDA 510(k) clearance with product code JOH and is classified under device class 2 for tracheostomy tubes and cuffs. This clearance indicates it is substantially equivalent to other legally marketed devices in this category.
What configurations are available for the Shiley XLT Tracheostomy Tube?
The Shiley XLT Tracheostomy Tube is available in multiple configurations: with or without a TaperGuard cuff, and in extended length options for both proximal and distal portions. These variations allow clinicians to select the most appropriate option for patients with specific anatomical challenges.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Shiley™ XLT extended length tracheostomy tube - Medtronic, Shiley™ adult flexible tracheostomy tube XLT - Medtronic (UK), Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251313 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien llc
- FDA Applicant
- Covidien, LLC
Sources (1)
- FDA 510(k) K251313 24 fields · synced Oct 6, 2026