Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- BSDAnalyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling3Product Code
- LSZVentilator, High Frequency3Product Code
- LYMDevice, Cpr AssistUProduct Code
- MNQStimulator, Hypoglossal Nerve, Implanted, Apnea3Product Code
- NJKValve, Pulmonary3Product Code
- OAZOne-Way Air-Leak ValveFProduct Code
- OIRDiaphragmatic/Phrenic Nerve Laparoscopically-Implanted StimulatorFProduct Code
- OOYBronchial Thermoplasty System3Product Code
- PDRComputer-Assisted Personalized Sedation System3Product Code
- PNCCatheter IntroducerNProduct Code
- POILung Tissue Sealant For Lung Volume ReductionNProduct Code
- PSRImplanted Phrenic Nerve Stimulator For Central Sleep Apnea3Product Code
- QGZElectrical Tumor Treatment Fields3Product Code
- QKSInhaler, Metered Dose Or Dry Powder, Cder Or Cber LedNProduct Code
- QLIVaporizer, Cder Or Cber LedNProduct Code
- QOQNon-Continuous Ventilator For Emergency UseNProduct Code
- QORContinuous Ventilator, Minimal Ventilatory SupportNProduct Code
- QOUEmergency ResuscitatorNProduct Code
- QOWVentilatory Assistance HelmetNProduct Code
- QPRNeurological Stimulation For Emergency UseNProduct Code
- QRSDevice For Sleep Apnea Testing Based On Mandibular Movement2Product Code
- QSFSoftware Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents3Product Code
- QRGUltrasound Guided Nerve Block Assist2Product Code
- QVEAdjunctive Pain Measurement Device For Anesthesiology2Product Code
- QVTMonitor For Opioid Induced Impairment Of Oxygenation2Product Code
- QTBNitric Oxide Generator And Delivery System3Product Code
- QZWOver-The-Counter Device To Assess Risk Of Sleep Apnea2Product Code
- QWEHyperoxia Monitoring Device Adjunct To Pulse Oximetry2Product Code
- QXDSpinal Imaging System For Neuraxial Procedures2Product Code
- Submissions with No Product CodeMiscellaneous
- 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
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One-Way Air-Leak Valve
- Page Type
- Product Code
- Definition
- To restrict air flow to the target section of the lung. To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.
- Physical State
- This device is a small nitinol frame that has a polyurethane membrane over the Nitinol frame that acts as a plug to the targeted section of the lung.
- Technical Method
- The device is a nitonal frame with a polyurethane membrane over the Nitinol frame. The valve does not allow air into the targeted segment of the lung, but does allow air and mucus out of that lung section.
- Target Area
- The device is intended to occlude a section of lung.
- Review Panel
- Anesthesiology
- Submission Type
- HDE - Humanitarian Device Exemption
- Device Classification
- F
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
The FDA has not linked product code OAZ to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:
- The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
- The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
- The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.