21 CFR 868.6810 — Catheters, Suction, Tracheobronchial
Anesthesiology (AN) · Part 868 Subpart G—Miscellaneous · § 868.6810
Identification
A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.
Classification Rationale
Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 1 | 116 | |
| OFO | Airway Suction Kit | 1 | 0 | |
| OFR | Tracheobronchial Suction Catheter Kit | 1 | 0 | |
| OFS | Tracheal Suction Set | 1 | 0 | |
| OYI | Non-Bronchoscopic Bronchoalveolar Lavage Catheter | 1 | 1 |