| Device Type ID | 898 |
| Device Name | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Regulation Description | Percutaneous 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 | 870.1250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NFA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 898 |
| Device | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Product Code | NFA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous Catheter. |
| CFR Regulation Number | 870.1250 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 46 |
Filter | 36 |
Difficult To Remove | 31 |
Adverse Event Without Identified Device Or Use Problem | 27 |
Guidewire | 15 |
Material Deformation | 14 |
Break | 13 |
Detachment Of Device Component | 9 |
Fracture | 9 |
Retraction Problem | 8 |
Failure To Capture | 6 |
Entrapment Of Device | 6 |
Kinked | 5 |
Device Damaged By Another Device | 5 |
Burst Container Or Vessel | 5 |
Deflation Problem | 5 |
Tip | 5 |
Wire | 5 |
Use Of Device Problem | 4 |
Device Operates Differently Than Expected | 3 |
Inflation Problem | 3 |
Difficult To Fold Or Unfold | 3 |
Leak / Splash | 3 |
Peeled / Delaminated | 2 |
Hole In Material | 2 |
Material Separation | 2 |
Material Distortion | 2 |
Torn Material | 2 |
Material Integrity Problem | 2 |
Contamination During Use | 1 |
Migration Or Expulsion Of Device | 1 |
Physical Resistance | 1 |
Patient-Device Incompatibility | 1 |
Material Twisted / Bent | 1 |
Obstruction Of Flow | 1 |
Activation, Positioning Or Separation Problem | 1 |
Difficult To Open Or Close | 1 |
Device Dislodged Or Dislocated | 1 |
Looping | 1 |
Device Difficult To Setup Or Prepare | 1 |
Material Puncture / Hole | 1 |
No Apparent Adverse Event | 1 |
Blocked Connection | 1 |
Packaging Problem | 1 |
Material Rupture | 1 |
Device Damaged Prior To Use | 1 |
Flaked | 1 |
Difficult To Insert | 1 |
Component Or Accessory Incompatibility | 1 |
Unsealed Device Packaging | 1 |
Device Packaging Compromised | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Aspiration Issue | 1 |
Device-Device Incompatibility | 1 |
Device Contamination With Chemical Or Other Material | 1 |
| Total Device Problems | 304 |