# K082127: Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635

- Pathway: 510(k) (Special)
- Applicant: Medtronic Neurosurgery
- Decided: Aug 27, 2008 after 29 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: 6 generations back to K944222 (1995). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033850: Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide, Medtronic Neurosurgery (2004). Our reading of the summary gave K038850, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Medtronic PS Medical Strata NSC Valve and Shunt Assemblies”.
- K042465: PS Medical Strata II Valve, Medtronic Neurosurgery (2004) Summary page 1.
- K831678: P-S Medical CSF-Flow Control Valve-Bur, Pudenz-Schulte Medical Research Corp. (1983) Summary page 1.

## Most influential descendants
- K083076: Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836 (2008), 0 descendants of its own

## Recalls of this device
- Jan 17, 2017 · Class II · Z-1121-2017: Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (

## Indications for use
The Strata NSC Burr Hole Valves and Shunt Assemblies are shunt components 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 NSC 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 inorder to address changing patient needs.

Source page: https://510kreport.com/device/K082127
Methodology: https://510kreport.com/methodology