| Device Type ID | 1000 |
| Device Name | Marker, Ostia, Aorto-saphenous Vein |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KPK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1000 |
| Device | Marker, Ostia, Aorto-saphenous Vein |
| Product Code | KPK |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 878.4650 [🔎] |