Definition: Long Term Support Greater Than 6 Hours For Acute Respiratory Or Acute Cardiopulmonary Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.
| Device Type ID | 987 |
| Device Name | Dual Lumen Ecmo Cannula |
| Physical State | The Device Consists Of A Catheter With Dual Lumens. Holes In The Outer And Inner Lumens Allow For Ingress And Egress Of Blood. |
| Technical Method | The Device Is Inserted Into The Vasculature And Connected To Other Devices In The ECMO Circuit To Allow For Drainage And Reinfusion Of Blood During ECMO Procedures. |
| Target Area | The Device Is Inserted Into The Vasculature And Connected To The Extracorporeal Circuit To Allow For Circulation Of Blood. |
| Regulation Description | Extracorporeal Circuit And Accessories For Long-term Respiratory/cardiopulmonary Failure. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.4100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 987 |
| Device | Dual Lumen Ecmo Cannula |
| Product Code | PZS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Extracorporeal Circuit And Accessories For Long-term Respiratory/cardiopulmonary Failure. |
| CFR Regulation Number | 870.4100 [🔎] |