| Device Type ID | 805 |
| Device Name | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing. |
| 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 | 870.4210 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DWF |
| 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 | 805 |
| Device | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Product Code | DWF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing. |
| CFR Regulation Number | 870.4210 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANGIODYNAMICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BT COMPANIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDIAC ASSIST DIV. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
CARDIAC ASSIST, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CARDIOGARD MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET CARDIOPULMONARY GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 12 | |
MEDTRONIC, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 14 | |
SORIN | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SORIN GROUP ITALIA S.R.L | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPYDER MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
TERUMO CARDIOVASCULAR SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
THORATEC CORP (ABBOTT LABORATORIES) | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
THORATEC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VORTEX MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 81 |
Leak / Splash | 35 |
Break | 23 |
Fluid Leak | 23 |
Detachment Of Device Component | 20 |
Device Operates Differently Than Expected | 18 |
Device Misassembled During Manufacturing / Shipping | 16 |
Material Separation | 16 |
Insufficient Information | 15 |
Nonstandard Device | 14 |
Fracture | 14 |
Misassembled | 13 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 12 |
Kinked | 12 |
Detachment Of Device Or Device Component | 11 |
Device Dislodged Or Dislocated | 11 |
Migration Or Expulsion Of Device | 10 |
Crack | 10 |
Disconnection | 10 |
Cannula | 9 |
Loss Of Or Failure To Bond | 8 |
Difficult To Remove | 8 |
Device Operational Issue | 8 |
Tear, Rip Or Hole In Device Packaging | 8 |
Air Leak | 7 |
Material Rupture | 6 |
Manufacturing, Packaging Or Shipping Problem | 6 |
Connection Problem | 6 |
Particulates | 5 |
Material Integrity Problem | 5 |
Use Of Device Problem | 4 |
Appropriate Term/Code Not Available | 4 |
Material Split, Cut Or Torn | 4 |
Split | 4 |
Material Fragmentation | 4 |
Device Handling Problem | 4 |
Hole In Material | 3 |
Device Issue | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Partial Blockage | 3 |
Device Slipped | 3 |
Difficult To Position | 3 |
Needle | 3 |
Malposition Of Device | 3 |
Failure To Deliver | 3 |
No Flow | 3 |
Deflation Problem | 3 |
Device Displays Incorrect Message | 3 |
Delivered As Unsterile Product | 3 |
Balloon | 3 |
Infusion Or Flow Problem | 3 |
Material Twisted / Bent | 3 |
Bent | 3 |
Burst Container Or Vessel | 2 |
Cap | 2 |
Failure To Adhere Or Bond | 2 |
Device Inoperable | 2 |
Occlusion Within Device | 2 |
Increase In Pressure | 2 |
Suction Problem | 2 |
Positioning Problem | 2 |
Insufficient Flow Or Under Infusion | 2 |
Decrease In Suction | 2 |
Malfunction | 2 |
Component Falling | 2 |
Blocked Connection | 2 |
Pumping Stopped | 2 |
Mechanical Problem | 2 |
Component(s), Broken | 2 |
Improper Flow Or Infusion | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Material Deformation | 2 |
Fitting Problem | 2 |
Component Incompatible | 2 |
Clamp | 2 |
Device Packaging Compromised | 2 |
Material Protrusion / Extrusion | 1 |
Separation Failure | 1 |
Unsealed Device Packaging | 1 |
Loss Of Power | 1 |
Material Too Rigid Or Stiff | 1 |
Aspiration Issue | 1 |
Unintended Movement | 1 |
Motor | 1 |
Sticking | 1 |
Torn Material | 1 |
Filtration Problem | 1 |
Defective Device | 1 |
Stylet | 1 |
Collapse | 1 |
Noise, Audible | 1 |
Computer Software Problem | 1 |
Laser Tip Separation | 1 |
Material Erosion | 1 |
Flaked | 1 |
Restricted Flow Rate | 1 |
Device Damaged Prior To Use | 1 |
Difficult To Advance | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Deformation Due To Compressive Stress | 1 |
| Total Device Problems | 585 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Edwards Lifesciences, LLC | II | Dec-09-2015 |
| 2 | Edwards Lifesciences, LLC | II | Apr-02-2015 |
| 3 | Edwards Lifesciences, LLC | II | Nov-14-2014 |
| 4 | Edwards Lifesciences, LLC | II | Apr-16-2014 |
| 5 | LivaNova USA | II | Jan-23-2019 |
| 6 | Maquet Cardiopulmonary Ag | II | Jun-11-2018 |
| 7 | Medtronic Inc. Cardiac Rhythm Disease Management | II | Feb-20-2014 |
| 8 | Medtronic Perfusion Systems | II | Jan-30-2018 |
| 9 | Medtronic Perfusion Systems | II | Jul-10-2017 |
| 10 | Medtronic Perfusion Systems | III | Feb-26-2016 |
| 11 | Medtronic Perfusion Systems | II | Nov-12-2015 |
| 12 | Medtronic Perfusion Systems | II | Aug-19-2015 |
| 13 | Medtronic Perfusion Systems | II | Jun-26-2015 |
| 14 | OriGen Biomedical, Inc. | I | Nov-07-2018 |
| 15 | OriGen Biomedical, Inc. | II | Oct-18-2018 |
| 16 | OriGen Biomedical, Inc. | II | Oct-12-2018 |
| 17 | OriGen Biomedical, Inc. | I | Oct-20-2017 |
| 18 | OriGen Biomedical, Inc. | I | Apr-23-2015 |
| 19 | SPS Sterilization, Inc | II | Sep-13-2018 |
| 20 | Sorin Group USA, Inc. | II | Nov-08-2017 |
| 21 | Sorin Group USA, Inc. | II | Aug-10-2017 |
| 22 | Sorin Group USA, Inc. | II | Sep-08-2016 |
| 23 | Sorin Group USA, Inc. | II | Jul-08-2016 |
| 24 | Sorin Group USA, Inc. | III | Feb-25-2016 |
| 25 | Sorin Group USA, Inc. | II | Feb-16-2016 |
| 26 | Surge Medical Sales, LLC (DBA Surge Cardiovascular) | II | Oct-04-2018 |
| 27 | Terumo Cardiovascular Systems Corp | II | Oct-31-2014 |
| 28 | Terumo Cardiovascular Systems Corporation | II | Jul-23-2014 |
| 29 | Terumo Cardiovascular Systems Corporation | II | Mar-19-2014 |