510(k) K022554 ยท JXG Shunt, Central Nervous System And Components
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
| Applicant | Integra Neurosciences, Planisboro NJ, US |
| Decision | Substantially Equivalent, Aug 23, 2002 |
| Received | Aug 2, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022554
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2019 | Integra LifeSciences Corp. MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve
MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w
MoniTorr 10110 10-110 CSF Drainage System used with Pole Terminated |
JXG | None listed |
| May 20, 2019 | Integra LifeSciences Corp. MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System
Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.