The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit With Flex Adapter.
| Device ID | K133754 |
| 510k Number | K133754 |
| Device Name: | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08535 |
| Contact | Elizabeth Mcmeniman |
| Correspondent | Elizabeth Mcmeniman INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08535 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-09 |
| Decision Date | 2014-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M272VTUN1 | K133754 | 000 |
| M273VTUNACCESSORI0 | K133754 | 000 |
| M273VTUNCATHETER0 | K133754 | 000 |
| 00382830058049 | K133754 | 000 |
| M273VTUN1 | K133754 | 000 |