← FDA Medical Device Classifications
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
OYI · Class I — Low Risk (general controls) · Anesthesiology · 21 CFR 868.6810
Classification
- FDA Product Code
OYI- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 868.6810
- Review panel
- AN
- Medical specialty
- Anesthesiology
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 12
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown