| Device Type ID | 3719 |
| Device Name | Catheter, Ventricular |
| Regulation Description | Ventricular Catheter. |
| 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) |
| CFR Regulation Number | 882.4100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HCA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 3719 |
| Device | Catheter, Ventricular |
| Product Code | HCA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ventricular Catheter. |
| CFR Regulation Number | 882.4100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Appropriate Term/Code Not Available | 1 |
Fracture | 1 |
Device Operates Differently Than Expected | 1 |
Insufficient Information | 1 |
| Total Device Problems | 6 |