| Device Type ID | 893 |
| Device Name | Stabilizer, Heart |
| Regulation Description | Cardiovascular Surgical Instruments. |
| 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) Exempt |
| CFR Regulation Number | 870.4500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MWS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 893 |
| Device | Stabilizer, Heart |
| Product Code | MWS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cardiovascular Surgical Instruments. |
| CFR Regulation Number | 870.4500 [🔎] |
| Device Problems | |
|---|---|
Break | 57 |
Mechanical Problem | 13 |
Detachment Of Device Component | 8 |
Material Too Rigid Or Stiff | 3 |
Use Of Device Problem | 3 |
Suction Problem | 3 |
Unstable | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Pressure Problem | 2 |
Knob | 2 |
Insufficient Information | 2 |
Decrease In Suction | 2 |
Mechanics Altered | 1 |
Positioning Problem | 1 |
Device Packaging Compromised | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operates Differently Than Expected | 1 |
Component Missing | 1 |
Material Frayed | 1 |
Unintended System Motion | 1 |
Inadequate Service | 1 |
Connection Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 110 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Maquet Cardiovascular, LLC | II | Oct-24-2014 |
| 2 | Terumo Cardiovascular Systems Corporation | II | Feb-22-2017 |
| 3 | Terumo Cardiovascular Systems Corporation | II | Feb-14-2017 |