510(k) K083076 ยท JXG Shunt, Central Nervous System And Components
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
| Applicant | Medtronic Neurosurgery, Goleta CA, US |
| Decision | Substantially Equivalent, Nov 20, 2008 |
| Received | Oct 16, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2021 | Medtronic Neurosurgery Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs:
27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM,
27740 - SHUNT 27740 STRATA NSC SNA Open, Classified |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.