OYI — Non-Bronchoscopic Bronchoalveolar Lavage Catheter Class I
FDA product code OYI covers "Non-Bronchoscopic Bronchoalveolar Lavage Catheter", a Class I medical device regulated under 21 CFR 868.6810. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OYI
- Device Class
- Class I
- Regulation Number
- 868.6810
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K112562 | kimberly-clark | BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER | December 15, 2011 |