21 CFR 868.5720 — Tube, Bronchial (W/Wo Connector)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5720
Identification
A bronchial tube is a device used to differentially intubate a patient's bronchus (one of the two main branches of the trachea leading directly to the lung) in order to isolate a portion of lung distal to the tube.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BTS | Tube, Bronchial (W/Wo Connector) | 2 | 6 | Life-Sustaining |