510(k) K920156 ยท JXG Shunt, Central Nervous System And Components
CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY
| Applicant | Clinical Neuro Systems, LLC, Goleta CA, US |
| Decision | Substantially Equivalent, Mar 16, 1992 |
| Received | Jan 14, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920156
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.