21 CFR 868.5790 — Stylet, Tracheal Tube
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5790
Identification
A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BSR | Stylet, Tracheal Tube | 1 | 32 |
