| Device Type ID | 3679 |
| Device Name | Instrument, Shunt System Implantation |
| Regulation Description | Shunt System Implantation Instrument. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 882.4545 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GYK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 3679 |
| Device | Instrument, Shunt System Implantation |
| Product Code | GYK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Shunt System Implantation Instrument. |
| CFR Regulation Number | 882.4545 [🔎] |
| Device Problems | |
|---|---|
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 2 |