Definition: Used To Gain Access To The Cavities Of The Brain For Injection Of Material Into Or Removal Of Material From The Brain.
| Device Type ID | 3747 |
| Device Name | Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents) |
| 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 | NHC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3747 |
| Device | Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents) |
| Product Code | NHC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ventricular Catheter. |
| CFR Regulation Number | 882.4100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 8 |
Material Separation | 2 |
Fracture | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Hole In Material | 1 |
| Total Device Problems | 15 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | Aug-12-2018 |
| 2 | Cook Inc. | II | Dec-14-2015 |