The following data is part of a premarket notification filed by Integra Neurosciences with the FDA for Camino Intracranial Pressure Monitoring Catheter With Licox Imc Bolt Fitting, Model 110-4l.
| Device ID | K022553 |
| 510k Number | K022553 |
| Device Name: | CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA NEUROSCIENCES 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Contact | Nancy A Mathewson |
| Correspondent | Nancy A Mathewson INTEGRA NEUROSCIENCES 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-02 |
| Decision Date | 2002-08-20 |
| Summary: | summary |