| Device Type ID | 836 |
| Device Name | Catheter, Flow Directed |
| Regulation Description | Flow-directed 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 | 870.1240 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DYG |
| 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 | 836 |
| Device | Catheter, Flow Directed |
| Product Code | DYG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Flow-directed Catheter. |
| CFR Regulation Number | 870.1240 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 54 |
Pacing Problem | 43 |
Deflation Problem | 40 |
Material Rupture | 37 |
Inflation Problem | 34 |
Adverse Event Without Identified Device Or Use Problem | 26 |
Leak / Splash | 25 |
Incorrect Measurement | 21 |
Appropriate Term/Code Not Available | 12 |
Display Or Visual Feedback Problem | 12 |
Fluid Leak | 11 |
Detachment Of Device Component | 11 |
Balloon | 10 |
Balloon Leak(s) | 9 |
Air Leak | 7 |
Unable To Obtain Readings | 6 |
Difficult To Advance | 6 |
Device Operates Differently Than Expected | 6 |
Burst Container Or Vessel | 6 |
Break | 5 |
Material Separation | 5 |
Material Fragmentation | 4 |
Device Contamination With Chemical Or Other Material | 4 |
No Device Output | 4 |
Entrapment Of Device | 4 |
Balloon Burst | 4 |
Activation, Positioning Or Separation Problem | 3 |
Activation Failure Including Expansion Failures | 3 |
Flaked | 3 |
Kinked | 3 |
Unintended Movement | 2 |
Hole In Material | 2 |
Occlusion Within Device | 2 |
Failure To Capture | 2 |
Defective Component | 2 |
Device Sensing Problem | 1 |
Material Integrity Problem | 1 |
Gas Leak | 1 |
Difficult To Remove | 1 |
Device Difficult To Program Or Calibrate | 1 |
Connection Problem | 1 |
No Pacing | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Catheter | 1 |
No Apparent Adverse Event | 1 |
Material Puncture / Hole | 1 |
Signal Artifact | 1 |
Balloon Rupture | 1 |
Unsealed Device Packaging | 1 |
Mechanical Jam | 1 |
Device Handling Problem | 1 |
Partial Blockage | 1 |
Knotted | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Material Deformation | 1 |
Loose Or Intermittent Connection | 1 |
Difficult To Insert | 1 |
Device Damaged Prior To Use | 1 |
Malposition Of Device | 1 |
Difficult To Position | 1 |
Mechanical Problem | 1 |
Cut In Material | 1 |
Device Or Device Fragments Location Unknown | 1 |
Output Problem | 1 |
Packaging Problem | 1 |
| Total Device Problems | 458 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Edwards Lifesciences, LLC | I | Jan-31-2019 |
| 2 | Edwards Lifesciences, LLC | II | Jun-02-2015 |