Definition: A Ventricular Assist Device (VAD) Assists The Left Or Right Ventricle In Maintaining Circulatory Blood Flow. The Device Is Either Totally Or Partially Implanted In The Body.
| Device Type ID | 961 |
| Device Name | Pediatric Ventricular Assist Device |
| Physical State | Ventricular Assist Devices May Come In Many Shapes (depending On Pulsatile Or Continuous Flow, And Mechanism Of Function) And Sizes (depending On Size Of The Patient). They Utilize Different Functions To Achieve Replacement Of The Primary Function Of |
| Technical Method | Uses Mechanical Means To Replace Function Of The Left And/or Right Ventricles. For Left Ventricular Support, Blood Is Pumped From The Left Ventricle To The Aortic Arch. For Right Ventricular Support, Blood Is Pumped From The Right Ventricle To The Pu |
| Target Area | Heart; Cardiovascular System |
| 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 | HDE - Humanitarian Device Exem |
| CFR Regulation Number | 870.3545 [🔎] |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | PCK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 961 |
| Device | Pediatric Ventricular Assist Device |
| Product Code | PCK |
| Regulation Description | Ventricular Bypass (assist) Device. |
| CFR Regulation Number | 870.3545 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 1 |
Break | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 3 |