OYI · Non-Bronchoscopic Bronchoalveolar Lavage Catheter
Anesthesiology · 21 CFR 868.6810 · Class 1
Overview
| Product Code | OYI |
|---|---|
| Device Name | Non-Bronchoscopic Bronchoalveolar Lavage Catheter |
| Regulation | 21 CFR 868.6810 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K112562 | BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER | Kimberly-Clark | Dec 15, 2011 | SESE |
Top Applicants
- Kimberly-Clark — 1 clearance
