| Device Type ID | 848 |
| Device Name | Catheter, Continuous Flush |
| Regulation Description | Continuous Flush Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1210 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KRA |
| 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 | 848 |
| Device | Catheter, Continuous Flush |
| Product Code | KRA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Continuous Flush Catheter. |
| CFR Regulation Number | 870.1210 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABLATIVE SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANGIODYNAMICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BTG INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
EDWARDS LIFESCIENCES LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EDWARDS LIFESCIENCES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MERCATOR MEDSYSTEMS, | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MERCATOR MEDSYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
REX MEDICAL, L.P. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VASCULAR INSIGHTS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Catheter | 370 |
Break | 331 |
Adverse Event Without Identified Device Or Use Problem | 146 |
Physical Resistance | 120 |
Fracture | 94 |
Material Separation | 89 |
Aspiration Issue | 82 |
Device Displays Incorrect Message | 71 |
Difficult To Remove | 65 |
Burst Container Or Vessel | 57 |
Device Dislodged Or Dislocated | 48 |
Detachment Of Device Component | 47 |
Leak / Splash | 43 |
Obstruction Of Flow | 43 |
Device Damaged Prior To Use | 41 |
Shaft | 40 |
Entrapment Of Device | 36 |
Physical Resistance / Sticking | 34 |
Device Damaged By Another Device | 33 |
Balloon | 33 |
Tip | 32 |
Kinked | 31 |
Detachment Of Device Or Device Component | 29 |
Fitting Problem | 29 |
Material Integrity Problem | 25 |
Material Deformation | 24 |
Material Rupture | 21 |
Difficult To Advance | 19 |
Peeled / Delaminated | 16 |
Hole In Material | 16 |
Inflation Problem | 16 |
Guidewire | 15 |
Occlusion Within Device | 15 |
Device Operates Differently Than Expected | 13 |
Material Perforation | 13 |
Material Fragmentation | 12 |
Device Handling Problem | 12 |
Device Inoperable | 12 |
Material Puncture / Hole | 12 |
Deformation Due To Compressive Stress | 11 |
Device Contamination With Chemical Or Other Material | 11 |
Fluid Leak | 11 |
Delamination | 10 |
Appropriate Term/Code Not Available | 9 |
Deflation Problem | 7 |
Failure To Advance | 7 |
Torn Material | 7 |
Difficult To Insert | 7 |
Flaked | 7 |
Hub | 7 |
Electrical Shorting | 6 |
Positioning Problem | 5 |
Difficult To Open Or Remove Packaging Material | 5 |
Mechanical Problem | 5 |
Stretched | 5 |
Device Or Device Fragments Location Unknown | 5 |
Crack | 4 |
Partial Blockage | 4 |
Device Packaging Compromised | 4 |
Bent | 4 |
Failure To Prime | 3 |
Tear, Rip Or Hole In Device Packaging | 3 |
Use Of Device Problem | 3 |
No Flow | 3 |
Contamination / Decontamination Problem | 3 |
Split | 3 |
Insufficient Information | 3 |
Radiation Underexposure | 3 |
Disconnection | 3 |
Restricted Flow Rate | 2 |
Device Markings / Labelling Problem | 2 |
Improper Flow Or Infusion | 2 |
Cut In Material | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Difficult To Position | 2 |
Device Issue | 2 |
Complete Blockage | 2 |
Positioning Failure | 2 |
Coil | 2 |
Unraveled Material | 2 |
Wire | 2 |
Material Frayed | 2 |
No Apparent Adverse Event | 2 |
Component Missing | 2 |
Incorrect Measurement | 2 |
Device Difficult To Setup Or Prepare | 2 |
Port | 2 |
Device Stops Intermittently | 2 |
Tip Breakage | 2 |
Material Twisted / Bent | 2 |
Migration Or Expulsion Of Device | 2 |
Uncoiled | 1 |
Patient-Device Incompatibility | 1 |
Product Quality Problem | 1 |
Compatibility Problem | 1 |
Loss Of Or Failure To Bond | 1 |
Smoking | 1 |
Melted | 1 |
Difficult To Flush | 1 |
Failure To Deliver | 1 |
| Total Device Problems | 2406 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Angiodynamics, Inc. | II | Aug-18-2014 |
| 2 | Cook Inc. | II | Mar-02-2017 |
| 3 | Cook Inc. | II | Nov-06-2015 |
| 4 | Covidien | I | Feb-03-2015 |
| 5 | EKOS Corporation | II | Sep-21-2016 |
| 6 | EKOS Corporation | II | Feb-24-2016 |
| 7 | EKOS Corporation | II | Jul-20-2015 |
| 8 | Medtronic Inc. Cardiac Rhythm Disease Management | II | Apr-02-2015 |
| 9 | Merit Medical Systems, Inc. | II | Oct-31-2014 |
| 10 | Micro Therapeutics Inc, Dba Ev3 Neurovascular | I | Nov-09-2016 |
| 11 | Sequent Medical Inc | II | Oct-27-2016 |
| 12 | Vascular Insights, LLC | II | Mar-21-2018 |