21 CFR 868.5750 — Cuff, Tracheal Tube, Inflatable
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5750
Identification
An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BSK | Cuff, Tracheal Tube, Inflatable | 2 | 39 | 3rd Party, Life-Sustaining |
