Device Type ID | 2857 |
Device Name | Catheter, Percutaneous, Long Term, Intraspinal |
Review Panel | General Hospital |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | LNY |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2857 |
Device | Catheter, Percutaneous, Long Term, Intraspinal |
Product Code | LNY |
FDA Device Classification | Class 3 Medical Device |
Device Problems | |
---|---|
Catheter | 2 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Occlusion Within Device | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Device Operates Differently Than Expected | 1 |
Leak / Splash | 1 |
Fluid Leak | 1 |
Split | 1 |
Total Device Problems | 10 |