510(k) K902783 ยท JXG Shunt, Central Nervous System And Components
PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
| Applicant | Pudenz-Schulte Medical Research Corp., Goleta CA, US |
| Decision | Substantially Equivalent, Aug 8, 1990 |
| Received | Jun 26, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902783
| 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 |
| Dec 16, 2020 | Medtronic Neurosurgery REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems des Open, Classified |
JXG | None listed |
| Dec 16, 2020 | Medtronic Neurosurgery REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems des Open, Classified |
JXG | None listed |
| Dec 16, 2020 | Medtronic Neurosurgery REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems des Open, Classified |
JXG | None listed |
| Nov 26, 2013 | Medtronic Neurosurgery Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201.
Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.