The following data is part of a premarket notification filed by Integra Neurocare Llc. with the FDA for Ventrix True Tech Ventricular Tunneling Pressure Monitoring Kit, Model Nl960-v.
| Device ID | K002392 |
| 510k Number | K002392 |
| Device Name: | VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA NEUROCARE LLC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Contact | Nancy Mathewson |
| Correspondent | Nancy Mathewson INTEGRA NEUROCARE LLC. 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2000-11-02 |