MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
FDA 510(k) clearance K062599 · decided 2006-09-27
Clearance details
- K-number
- K062599
- Device name
- MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-09-01
- Decision date
- 2006-09-27
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- JXG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Plainsboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-1 recall (Z-1310-2019) | Integra LifeSciences Corp. | 2019-05-20 |
| MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: T recall (Z-1311-2019) | Integra LifeSciences Corp. | 2019-05-20 |