Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
- BRXStool, Anesthesia1Product Code
- BRYCabinet, Table And Tray, Anesthesia1Product Code
- BSYCatheters, Suction, Tracheobronchial1Product Code
- BTICompressor, Air, Portable2Product Code
- BXJClip, Nose1Product Code
- BXKGas, Calibration (Specified Concentration)1Product Code
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)1Product Code
- CAMYoke Assembly, Medical Gas1Product Code
- CCXSupport, Patient Position1Product Code
- OFOAirway Suction Kit1Product Code
- OFRTracheobronchial Suction Catheter Kit1Product Code
- OFSTracheal Suction Set1Product Code
- OYINon-Bronchoscopic Bronchoalveolar Lavage Catheter1Product Code
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Non-Bronchoscopic Bronchoalveolar Lavage Catheter
- Page Type
- Product Code
- Definition
- To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.
- Physical State
- This device is a catheter
- Technical Method
- The device is inserted into a patient's lungs to collect bronchoalveolar labage specimens
- Target Area
- Lungs
- Regulation Medical Specialty
- Anesthesiology
- Review Panel
- Anesthesiology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 868.6810
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 868.6810 Tracheobronchial suction catheter
§ 868.6810 Tracheobronchial suction catheter.
(a) Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.
(b) Classification. 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.
[47 FR 31142, July 16, 1982, as amended at 65 FR 2314, Jan. 14, 2000]