| Device Type ID | 795 |
| Device Name | Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Cardiotomy Return Sucker. |
| 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 | 870.4420 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DTS |
| 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 | 795 |
| Device | Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Product Code | DTS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Cardiotomy Return Sucker. |
| CFR Regulation Number | 870.4420 [🔎] |
| Device Problems | |
|---|---|
Over-Sensing | 34 |
Device Dislodged Or Dislocated | 21 |
High Capture Threshold | 14 |
Low Impedance | 11 |
Failure To Capture | 9 |
High Impedance | 8 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Device Sensing Problem | 5 |
Failure To Sense | 5 |
Device Operates Differently Than Expected | 3 |
Insulation | 3 |
Difficult To Remove | 3 |
Decreased Sensitivity | 3 |
Sensing Intermittently | 3 |
Break | 3 |
Difficult To Advance | 2 |
Detachment Of Device Component | 2 |
Under-Sensing | 2 |
Retraction Problem | 2 |
Capturing Problem | 2 |
Failure To Advance | 2 |
Particulates | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Intermittent Capture | 1 |
Entrapment Of Device | 1 |
Low Sensing Threshold | 1 |
Mechanical Problem | 1 |
Device Slipped | 1 |
Helifix Coil | 1 |
| Total Device Problems | 150 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | International Biophysics Corp. | II | Aug-19-2015 |