| Device Type ID | 791 |
| Device Name | Reservoir, Blood, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Blood Reservoir. |
| 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 | 870.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DTN |
| 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 | 791 |
| Device | Reservoir, Blood, Cardiopulmonary Bypass |
| Product Code | DTN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Blood Reservoir. |
| CFR Regulation Number | 870.4400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CIRCULATORY TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET CARDIOPULMONARY GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SORIN GROUP ITALIA S.R.L | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 14 |
Leak / Splash | 10 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 9 |
Device Operates Differently Than Expected | 4 |
Infusion Or Flow Problem | 4 |
Device Inoperable | 3 |
Component(s), Broken | 3 |
Disconnection | 3 |
Detachment Of Device Component | 3 |
Air Leak | 2 |
Positioning Problem | 2 |
Crack | 2 |
Break | 2 |
Electrical /Electronic Property Problem | 2 |
Increase In Pressure | 2 |
Device Displays Incorrect Message | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Coagulation In Device Or Device Ingredient | 1 |
Reservoir | 1 |
Structural Problem | 1 |
Material Disintegration | 1 |
Difficult To Remove | 1 |
Filtration Problem | 1 |
Material Fragmentation | 1 |
Unsealed Device Packaging | 1 |
Device Issue | 1 |
Device Packaging Compromised | 1 |
Environmental Particulates | 1 |
Pressure Problem | 1 |
| Total Device Problems | 79 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Circulatory Technology Inc | II | Mar-01-2018 |
| 2 | Circulatory Technology Inc | III | Oct-07-2016 |
| 3 | Circulatory Technology Inc | II | Sep-15-2016 |
| 4 | Circulatory Technology Inc | II | Jun-27-2016 |
| 5 | Datascope Corporation | II | May-08-2018 |
| 6 | Medtronic Perfusion Systems | II | Feb-20-2018 |