# K083076: Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836

- Pathway: 510(k) (Special)
- Applicant: Medtronic Neurosurgery
- Decided: Nov 20, 2008 after 35 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944222 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042465: PS Medical Strata II Valve, Medtronic Neurosurgery (2004) Summary page 1.
- K082127: Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635, Medtronic Neurosurgery (2008) Summary page 1.

## Recalls of this device
- Jan 11, 2021 · Class II · Z-1116-2021: Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

## Indications for use
The Strata Burr Hole 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 Strata Burr Hole valve allows the physician to non-invasively adjust the pressure/ flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs.

Source page: https://510kreport.com/device/K083076
Methodology: https://510kreport.com/methodology