510(k) K033850 ยท JXG Shunt, Central Nervous System And Components
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
| Applicant | Medtronic Neurosurgery, Goleta CA, US |
| Decision | Substantially Equivalent, Jan 13, 2004 |
| Received | Dec 11, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033850
| 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 |
| 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.