# K042198: PS Medical Neurosurgical Implants

- Pathway: 510(k) (Special)
- Applicant: Medtronic Neurosurgery
- Decided: Sep 24, 2004 after 42 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
Longest line of descent: 5 generations back to K944222 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K803257: CSG-Flow Control Valve, Pudenz-Schulte Medical Research Corp. (1981) Summary page 1.
- K831678: P-S Medical CSF-Flow Control Valve-Bur, Pudenz-Schulte Medical Research Corp. (1983) Summary page 1.
- K841442: P-S Medical CSF-Flow Control Valve-, P-S Medical (1984) Summary page 1.
- K833822: P-S Medical CSF Access Dev 15MM/25MM, Pudenz-Schulte Medical Research Corp. (1984) Summary page 1.
- K873247: CSF-Flow Control Valve, Ultra Small, Pudenz-Schulte Medical Research Corp. (1987) Summary page 1.
- K874468: P-S Medical Ventricular Access Port, Pudenz-Schulte Medical Research Corp. (1988) Summary page 1.
- K874498: CSF-Ventriculostomy Reservoir, Pudenz-Schulte Medical Research Corp. (1988) Summary page 1.
- K900676: CSF-Flow Control Valve, Cylindrical & Shunt Kit, Pudenz-Schulte Medical Research Corp. (1990) Summary page 1.
- K902783: PS Medical Delta CSF-Flow Control Valve, Pudenz-Schulte Medical Research Corp. (1990) Summary page 1.
- K911410: PS Medical Button Valve, Pudenz-Schulte Medical Research Corp. (1991) Summary page 1.
- K913412: PS Medical CSF-Access Device, Pudenz-Schulte Medical Research Corp. (1993) Summary page 1.
- K934545: PS Medical Delta Burr Hole Valve, Pudenz-Schulte Medical Research Corp. (1994) Summary page 1.
- K951258: PS Medical Bioglide CSF-Flow Control Shunt Kit, Pudenz-Schulte Medical Research Corp. (1995) Summary page 1.
- K991502: Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022, Medtronic PS Medical (2000) Summary page 1.
- K012052: Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855, Medtronic PS Medical (2002) Summary page 1.
- K033850: Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide, Medtronic Neurosurgery (2004) Summary page 1.

## Indications for use
CSF Shunt components are designed to provide controlled Cerebrospinal Fluid (CSF) flow from the ventricles of the brain to the right atrium of the heart or the peritoneal cavity.

Source page: https://510kreport.com/device/K042198
Methodology: https://510kreport.com/methodology