DEN210006 is an FDA 510(k) submission for the Hemolung Respiratory Assist System. This device is classified as a Extracorporeal System For Carbon Dioxide Removal (Class II - Special Controls, product code QOH).
Submitted by Alung Technologies, Inc. (Pittsburgh, US). The FDA issued a Not Cleared (DENG) decision on November 13, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4150. An Extracorporeal System For Carbon Dioxide Removal Is A System Of Devices And Accessories That Provides Assisted Extracorporeal Carbon Dioxide Removal From The Patient's Blood In Patients With Acute Respiratory Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent. The Main Devices And Accessories Of The System Include, But Are Not Limited To, The Console (hardware), Software, And Disposables, Including, But Not Limited To, A Gas Exchanger, Blood Pump, Cannulae, Tubing, Filters, And Other Accessories (e.g., Monitors, Detectors, Sensors, Connectors)..
| 510(k) Number | DEN210006 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 04, 2021 |
| Decision Date | November 13, 2021 |
| Days to Decision | 254 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | QOH - Extracorporeal System For Carbon Dioxide Removal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4150 |
| Definition | An Extracorporeal System For Carbon Dioxide Removal Is A System Of Devices And Accessories That Provides Assisted Extracorporeal Carbon Dioxide Removal From The Patient's Blood In Patients With Acute Respiratory Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent. The Main Devices And Accessories Of The System Include, But Are Not Limited To, The Console (hardware), Software, And Disposables, Including, But Not Limited To, A Gas Exchanger, Blood Pump, Cannulae, Tubing, Filters, And Other Accessories (e.g., Monitors, Detectors, Sensors, Connectors). |