# K991502: Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic PS Medical
- Decided: Sep 12, 2000 after 502 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K042198: PS Medical Neurosurgical Implants (2004), 0 descendants of its own

## Indications for use
The polyurethane-coated Delta Valves, polyurethane-coated CSF-Flow Control Valves, Contoured, and Burr Hole are components of polyurethane shunt systems designed for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity. The Polyurethane shunt and shunt components are designed to eliminate patient exposure to silicone elastomer. The polyurethane-coated Delta Valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient sits, stands, or is held erect).

Source page: https://510kreport.com/device/K991502
Methodology: https://510kreport.com/methodology