| Device Type ID | 826 |
| Device Name | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Coronary Pressure Gauge. |
| 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) |
| CFR Regulation Number | 870.4310 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 826 |
| Device | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Product Code | DXS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Coronary Pressure Gauge. |
| CFR Regulation Number | 870.4310 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Perfusion Systems | II | Jul-10-2017 |