| Device Type ID | 789 |
| Device Name | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, Or Fitting. |
| 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 | 870.4290 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DTL |
| 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 | 789 |
| Device | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Product Code | DTL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, Or Fitting. |
| CFR Regulation Number | 870.4290 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GALT MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
THERAGENICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 114 |
Tear, Rip Or Hole In Device Packaging | 22 |
Infusion Or Flow Problem | 17 |
Suction Problem | 11 |
Device Contamination With Chemical Or Other Material | 9 |
Air Leak | 9 |
Unable To Obtain Readings | 7 |
Crack | 7 |
No Flow | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Improper Device Output | 5 |
Material Integrity Problem | 5 |
Fluid Leak | 5 |
Device Operates Differently Than Expected | 4 |
Use Of Device Problem | 4 |
Delivered As Unsterile Product | 3 |
Defective Device | 3 |
Physical Resistance / Sticking | 3 |
Improper Flow Or Infusion | 2 |
Insufficient Flow Or Under Infusion | 2 |
Connection Problem | 2 |
Hemo Valve | 2 |
Gauges/Meters | 2 |
Fracture | 2 |
Suction Failure | 2 |
Decoupling | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Physical Resistance | 1 |
Implant Mobility NOS (Not Otherwise Specified) | 1 |
No Apparent Adverse Event | 1 |
Component Missing | 1 |
Obstruction Of Flow | 1 |
Difficult To Open Or Close | 1 |
Device Damaged Prior To Use | 1 |
Malfunction | 1 |
Difficult To Advance | 1 |
Disconnection | 1 |
Difficult To Insert | 1 |
Kinked | 1 |
Loose Or Intermittent Connection | 1 |
Output Problem | 1 |
Missing Value Reason | 1 |
Filtration Problem | 1 |
Mechanical Problem | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Adapter (Adaptor) | 1 |
Pressure Problem | 1 |
Excess Flow Or Over-Infusion | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Device Packaging Compromised | 1 |
Mechanical Jam | 1 |
| Total Device Problems | 280 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | May-09-2018 |
| 2 | Dokitz NovoSci | II | Nov-06-2014 |
| 3 | Medtronic Perfusion Systems | II | Jul-10-2017 |
| 4 | Terumo Cardiovascular Systems Corp | II | Jun-23-2015 |
| 5 | Terumo Cardiovascular Systems Corporation | II | Jun-21-2018 |
| 6 | Vascular Solutions, Inc. | I | Apr-07-2016 |