| Device Type ID | 2515 |
| Device Name | Catheter, Percutaneous, Intraspinal, Short Term |
| Regulation Description | Anesthesia Conduction Catheter. |
| Regulation Medical Specialty | Anesthesiology |
| 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 | 510(k) |
| CFR Regulation Number | 868.5120 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MAJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2515 |
| Device | Catheter, Percutaneous, Intraspinal, Short Term |
| Product Code | MAJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Anesthesia Conduction Catheter. |
| CFR Regulation Number | 868.5120 [🔎] |
| Device Problems | |
|---|---|
Break | 6 |
Material Integrity Problem | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Device Operates Differently Than Expected | 2 |
Fracture | 1 |
Device Or Device Fragments Location Unknown | 1 |
| Total Device Problems | 18 |