| Device Type ID | 739 |
| Device Name | Occluder, Catheter Tip |
| Regulation Description | Catheter Tip Occluder. |
| 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 | 870.1370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DQT |
| 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 | 739 |
| Device | Occluder, Catheter Tip |
| Product Code | DQT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Catheter Tip Occluder. |
| CFR Regulation Number | 870.1370 [🔎] |
| Device Problems | |
|---|---|
Activation, Positioning Or Separation Problem | 7 |
Mechanical Problem | 6 |
Material Fragmentation | 5 |
Break | 3 |
Device Or Device Fragments Location Unknown | 2 |
Crack | 1 |
Knotted | 1 |
Fracture | 1 |
| Total Device Problems | 26 |