MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM— 510(k) K071505
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K071505 for MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM, Substantially Equivalent on 2007-08-06. Applicant: Integra LifeSciences Corporation.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code GWM
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Planisboro, NJ, US
Adverse events under product code GWM
product code GWM- Death
- 21
- Injury
- 732
- Malfunction
- 2,063
- Other
- 1
- Total
- 2,817
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.