Definition: A Ventricular Bypass (assist) Device Is A Device That Assists The Left Or Right Ventricle In Maintaining Circulatory Blood Flow For
| Device Type ID | 950 |
| Device Name | Ventricular Bypass (assist) Device |
| Physical State | A Ventricular Bypass (assist) Device Is A Device That Assists The Left Or Right Ventricle In Maintaining Circulatory Blood Flow For < 6 Hours. The Device Is Either Totally Or Partially Implanted In The Body. |
| Technical Method | A Ventricular Bypass (assist) Device Is A Device That Assists The Left Or Right Ventricle In Maintaining Circulatory Blood Flow For < 6 Hours. The Device Is Either Totally Or Partially Implanted In The Body. |
| Target Area | A Ventricular Bypass (assist) Device Is A Device That Assists The Left Or Right Ventricle In Maintaining Circulatory Blood Flow For < 6 Hours. The Device Is Either Totally Or Partially Implanted In The Body. |
| Regulation Description | Ventricular Bypass (assist) Device. |
| 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 | PMA |
| CFR Regulation Number | 870.3545 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OKR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 950 |
| Device | Ventricular Bypass (assist) Device |
| Product Code | OKR |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Ventricular Bypass (assist) Device. |
| CFR Regulation Number | 870.3545 [🔎] |
| Device Problems | |
|---|---|
Pumping Problem | 6 |
Obstruction Of Flow | 6 |
Occlusion Within Device | 2 |
Connection Problem | 1 |
Computer Operating System Problem | 1 |
Pumping Stopped | 1 |
| Total Device Problems | 17 |