NXA · Tracheotomy Care Kit
Anesthesiology · 21 CFR 868.5800 · Class 2
Overview
| Product Code | NXA |
|---|---|
| Device Name | Tracheotomy Care Kit |
| Regulation | 21 CFR 868.5800 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K844051 | SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT | Washington-Greene County Branch Pennsylvania Assoc | Jan 18, 1985 | SESE |
Top Applicants
- Washington-Greene County Branch Pennsylvania Assoc — 1 clearance
