Definition: Providing Temporary Partial Or Full Right Heart Circulatory Support.
| Device Type ID | 986 |
| Device Name | Temporary Non-roller Type Right Heart Support Blood Pump |
| Physical State | Rotor Or Axial Type Pump Manufactured Of Various Materials. Single Use, Disposable. |
| Technical Method | Assists With Partial Or Full Right Heart Blood Circulation Either During An Adjunctive Procedure Where The Patient Requires Hemodynamic Stability, Or A Temporary Use Of The Device To Unload The Right Heart To Give It Time To Recover From An Acute Con |
| Target Area | Heart. |
| Regulation Description | Nonroller-type Blood Pump. |
| 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 | 870.4360 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PYX |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 986 |
| Device | Temporary Non-roller Type Right Heart Support Blood Pump |
| Product Code | PYX |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Nonroller-type Blood Pump. |
| CFR Regulation Number | 870.4360 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Appropriate Term/Code Not Available | 2 |
Use Of Device Problem | 1 |
No Apparent Adverse Event | 1 |
Difficult To Remove | 1 |
Device Operates Differently Than Expected | 1 |
Human-Device Interface Problem | 1 |
Material Twisted / Bent | 1 |
Break | 1 |
Crack | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Difficult To Position | 1 |
Difficult To Insert | 1 |
Kinked | 1 |
Material Deformation | 1 |
Material Separation | 1 |
Unexpected Shutdown | 1 |
| Total Device Problems | 23 |