Definition: Temporary Circulatory Support < 6 Hours Of Use During Off-pump Bypass (OPCAB).
| Device Type ID | 960 |
| Device Name | Temporary Cardiac Support Blood Pump |
| Physical State | A Catheter Based Axial Flow Impeller Pump That Is Implanted Within The Heart. The Pump Unloads The Heart By Actively Pumping Blood From The Left Veitricle To The Aorta For Durations Of 6 Hours Or Less. |
| Technical Method | The Blood Pump Is Used To Support The Circulation During Surgical Procedures (lasting < 6 Hours) With Or Without The Use Of An Oxygenator. |
| Target Area | Intracardiac. |
| 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) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.4360 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PBL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 960 |
| Device | Temporary Cardiac Support Blood Pump |
| Product Code | PBL |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Nonroller-type Blood Pump. |
| CFR Regulation Number | 870.4360 [🔎] |
| Device Problems | |
|---|---|
Positioning Problem | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Patient-Device Incompatibility | 2 |
Fracture | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Device Displays Incorrect Message | 1 |
Failure To Pump | 1 |
Migration Or Expulsion Of Device | 1 |
Difficult To Remove | 1 |
Device Operates Differently Than Expected | 1 |
Device Operational Issue | 1 |
Infusion Or Flow Problem | 1 |
Defective Component | 1 |
Failure To Advance | 1 |
Compatibility Problem | 1 |
Material Integrity Problem | 1 |
Entrapment Of Device | 1 |
Kinked | 1 |
Pumping Stopped | 1 |
Torn Material | 1 |
Detachment Of Device Component | 1 |
Device Issue | 1 |
Pumping Problem | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 30 |