510(k) K133754
K133754 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER". The FDA issued a decision of Substantially Equivalent on March 6, 2014. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2014
- Date Received
- December 9, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Monitoring, Intracranial Pressure
- Device Class
- Class II
- Regulation Number
- 882.1620
- Review Panel
- NE
- Submission Type