510(k) K841442 ยท JXG Shunt, Central Nervous System And Components
P-S MEDICAL CSF-FLOW CONTROL VALVE-
| Applicant | P-S Medical, Walker MI, US |
| Decision | Substantially Equivalent, Apr 19, 1984 |
| Received | Apr 6, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K841442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2021 | Medtronic Neurosurgery Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs:
22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW
22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L
22011 M - Open, Classified |
JXG | None listed |
| Nov 26, 2013 | Medtronic Neurosurgery CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022;
CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.