← Back to catalogue

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430 +14 mor…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233341

by Covidien llc

Identifiers

510(k) Number
K233341 FDA 510(k)
FDA Product Code
BTR FDA 510(k)
Models / Variants
87430 FDA 510(k)
87435 FDA 510(k)
87440 FDA 510(k)
87445 FDA 510(k)
87450 FDA 510(k)
87455 FDA 510(k)
87460 FDA 510(k)
87465 FDA 510(k)
87470 FDA 510(k)
87475 FDA 510(k)
87480 FDA 510(k)
87485 FDA 510(k)
87490 FDA 510(k)
87495 FDA 510(k)
87410 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5730 FDA 510(k)
Regulation Number
868.5730 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Shiley Oral/Nasal Endotracheal Tube with Intermediate Cuff is a tracheal tube intended for use in oral or nasal intubation of the trachea for anesthesia and airway management. It is designed for pediatric through adult patients and is made with latex-free, non-DEHP PVC material that softens at body temperature.

The device is supplied in various sizes as indicated by the model numbers and is intended for single-use. It is MRI safe and has received FDA 510(k) clearance with the product code BTR. The device is regulated under 21 CFR 868.5730 and is classified as Class II.

Frequently asked questions

What is the Shiley Oral/Nasal Endotracheal Tube with Intermediate Cuff used for?

The Shiley Oral/Nasal Endotracheal Tube with Intermediate Cuff is designed for oral or nasal intubation of the trachea for anesthesia and airway management in pediatric through adult patients. It features an intermediate cuff and is made with latex-free, non-DEHP PVC material that softens at body temperature.

What sizes are available for the Shiley Endotracheal Tube?

The Shiley Endotracheal Tube is supplied in various sizes as indicated by the model numbers 87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, and 87410, accommodating pediatric through adult patients.

Is the Shiley Endotracheal Tube single-use or reusable?

The Shiley Oral/Nasal Endotracheal Tube with Intermediate Cuff is intended for single-use only. It should not be reused on different patients due to infection control and safety considerations.

What regulatory status does the Shiley Endotracheal Tube have?

The Shiley Endotracheal Tube has received FDA 510(k) clearance with product code BTR and is classified as Class II medical device. It is regulated under 21 CFR 868.5730 and is MRI safe.

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™ Oral-Nasal Endotracheal Tube with Intermediate Cuff, Shiley™ Oral-Nasal Endotracheal Tube | Medtronic, Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430 ..., Shiley? Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Covidien llc
FDA Applicant
Covidien, LLC

Sources (1)

  • FDA 510(k) K233341 24 fields · synced Oct 1, 2026