# K040943: Medtronic PS Medical Strata Valve

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Jun 15, 2004 after 64 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 5 cite it directly.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic PS Medical Strata Valve: named in the summary without a submission number

## Most influential descendants
- K042465: PS Medical Strata II Valve (2004), 19 descendants of its own
- K060681: Medtronic PS Medical Strata Type Value (2006), 7 descendants of its own
- K062009: Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T (2007), 6 descendants of its own
- K103003: Aesculap- Meithke Progav Programmable Shunt System (2010), 4 descendants of its own
- K110206: Aesculap- Meithke Shunt System (2011), 3 descendants of its own

## Indications for use
The Strata® Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/flow performance level pre- and post-implantation by using an external magnetic Adjustment Tool without the need for radiographic confirmation.

Source page: https://510kreport.com/device/K040943
Methodology: https://510kreport.com/methodology