| Device Type ID | 2794 |
| Device Name | Port & Catheter, Implanted, Subcutaneous, Intraventricular |
| Regulation Description | Central Nervous System Fluid Shunt And Components. |
| Regulation Medical Specialty | Neurology |
| 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 | 882.5550 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LKG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2794 |
| Device | Port & Catheter, Implanted, Subcutaneous, Intraventricular |
| Product Code | LKG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Central Nervous System Fluid Shunt And Components. |
| CFR Regulation Number | 882.5550 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 5 |
Fracture | 2 |
Fluid Leak | 2 |
Break | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 11 |