Definition: For Short-term Prevention Of Pulmonary Embolism (PE)
| Device Type ID | 975 |
| Device Name | Short-term Intravascular Filter Catheter |
| Physical State | Filter Attached To A Catheter |
| Technical Method | Mechanically Filters The Bloodstream To Capture Blood Clots |
| Target Area | Peripheral Vasculature (vein), Inferior Vena Cava (IVC) |
| Regulation Description | Cardiovascular Intravascular Filter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3375 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 975 |
| Device | Short-term Intravascular Filter Catheter |
| Product Code | PNS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiovascular Intravascular Filter. |
| CFR Regulation Number | 870.3375 [🔎] |
| Device Problems | |
|---|---|
Filter | 4 |
Fracture | 4 |
Difficult To Remove | 1 |
| Total Device Problems | 9 |