510(k) K082127 ยท JXG Shunt, Central Nervous System And Components
STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635
| Applicant | Medtronic Neurosurgery, Goleta CA, US |
| Decision | Substantially Equivalent, Aug 27, 2008 |
| Received | Jul 29, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2017 | Medtronic Neurosurgery Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers.
Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.