| Device Type ID | 799 |
| Device Name | Oxygenator, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Oxygenator. |
| 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 | 870.4350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DTZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 799 |
| Device | Oxygenator, Cardiopulmonary Bypass |
| Product Code | DTZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Oxygenator. |
| CFR Regulation Number | 870.4350 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARDIAC ASSIST DIV. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDIAC ASSIST, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GEMAR | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET CARDIOPULMONARY GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
MEDTRONIC, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
SORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SORIN GROUP ITALIA S.R.L | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SORIN GROUP ITALIA S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
TERUMO CARDIOVASCULAR SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
XENIOS AG | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Leak / Splash | 610 |
Fluid Leak | 446 |
Device Operates Differently Than Expected | 107 |
Break | 99 |
Use Of Device Problem | 95 |
Device Damaged Prior To Use | 92 |
Pressure Problem | 85 |
Increase In Pressure | 79 |
Crack | 52 |
Filtration Problem | 49 |
Connection Problem | 46 |
Infusion Or Flow Problem | 45 |
Device Contamination With Chemical Or Other Material | 38 |
Tube | 37 |
Improper Flow Or Infusion | 37 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 37 |
Fracture | 37 |
Coagulation In Device Or Device Ingredient | 36 |
Air Leak | 33 |
Disconnection | 27 |
Occlusion Within Device | 27 |
Device Operational Issue | 26 |
Device Issue | 25 |
Medical Gas Supply Problem | 23 |
Gradient Increase | 16 |
Material Deformation | 16 |
Complete Blockage | 15 |
Insufficient Flow Or Under Infusion | 15 |
Defective Component | 15 |
Temperature Problem | 12 |
Detachment Of Device Component | 12 |
Output Problem | 11 |
Connector | 11 |
Low Readings | 11 |
Component Missing | 11 |
No Flow | 10 |
Obstruction Of Flow | 9 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Tear, Rip Or Hole In Device Packaging | 9 |
Packaging Problem | 9 |
Incorrect Device Or Component Shipped | 8 |
Lead Tip | 8 |
Out-Of-Box Failure | 7 |
Partial Blockage | 7 |
Manufacturing, Packaging Or Shipping Problem | 7 |
Failure To Adhere Or Bond | 6 |
Device Displays Incorrect Message | 6 |
Insufficient Information | 5 |
Detachment Of Device Or Device Component | 5 |
Decrease In Pressure | 5 |
Joint | 4 |
Kinked | 4 |
Misassembled | 4 |
Shipping Damage Or Problem | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Bubble Detector | 4 |
Material Integrity Problem | 3 |
Port | 3 |
Failure To Prime | 3 |
Particulates | 3 |
Insufficient Heating | 3 |
Loose Or Intermittent Connection | 3 |
Malfunction | 3 |
Device Markings / Labelling Problem | 3 |
Device Alarm System | 3 |
Pumping Stopped | 3 |
Dent In Material | 3 |
Temperature Probe | 3 |
Pumping Problem | 3 |
Device Handling Problem | 2 |
Hole In Material | 2 |
Sharp/jagged/rough/etched/scratched | 2 |
Fitting Problem | 2 |
Inadequate Filtration Process | 2 |
Mechanical Problem | 2 |
Difficult To Position | 2 |
Display Or Visual Feedback Problem | 2 |
Probe | 2 |
Defective Device | 2 |
Valve, Outlet Port | 2 |
Restricted Flow Rate | 2 |
Positioning Problem | 2 |
Outlet | 2 |
Locking Mechanism Failure | 2 |
Ventilation Problem In Device Environment | 2 |
Gas Output Problem | 2 |
Melted | 2 |
Manifold | 2 |
Appropriate Term/Code Not Available | 2 |
Implant Mobility NOS (Not Otherwise Specified) | 2 |
Product Quality Problem | 2 |
Contamination During Use | 2 |
Improper Device Output | 2 |
Power Problem | 1 |
Decoupling | 1 |
Inaccurate Flow Rate | 1 |
Performance | 1 |
Device Stops Intermittently | 1 |
False Alarm | 1 |
Patient-Device Incompatibility | 1 |
| Total Device Problems | 2561 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | LivaNova USA | II | May-23-2018 |
| 2 | Maquet Cardiovascular Us Sales, Llc | I | Nov-28-2018 |
| 3 | Maquet Cardiovascular Us Sales, Llc | II | Apr-12-2016 |
| 4 | Maquet Cardiovascular Us Sales, Llc | II | May-28-2015 |
| 5 | Maquet Cardiovascular Us Sales, Llc | II | Dec-24-2014 |
| 6 | Medtronic Inc | II | Dec-20-2016 |
| 7 | Medtronic Perfusion Systems | II | Dec-16-2014 |