510(k) K042465 ยท JXG Shunt, Central Nervous System And Components
PS MEDICAL STRATA II VALVE
| Applicant | Medtronic Neurosurgery, Goleta CA, US |
| Decision | Substantially Equivalent, Oct 19, 2004 |
| Received | Sep 13, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2021 | Medtronic Neurosurgery Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers:
24048 - VALVE 24048 DELTA RGL PL 0.5,
24053 - CHAMBER 24053 DELTA,
24147 - VALVE 24147 DELTA SML P Open, Classified |
JXG | None listed |
| 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 |
| 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 |
| Nov 26, 2013 | Medtronic Neurosurgery Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848.
Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into th Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.