# K152897: Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Mar 4, 2016 after 155 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: 1 generation back to K861377 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861377: Standard/Pediatric Cordis Hydrocephalus Valves, Cordis Corp. (1986) Summary page 4.
- K903844: Omnishunt System for Ventricular Shunting, Cordis Corp. (1990) Summary page 4.
- K925810: Cordis Polypropylene Burr Hole Reservoir, Cordis Corp. (1994) Summary page 4.
- K932429: Cordis Gravity Compensating Accessory, Cordis Corp. (1994) Summary page 4.

## Indications for use
Integra DP Valve Systems Integra DP Valve Systems are implantable devices which serve as a parallel flow pathway to divert cerebrospinal fluid (CSF) from the cerebral ventricles to an appropriate drainage site. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus or other conditions in which CSF flow and/or absorption is impaired. The very low pressure valve (blue band) is used for postoperative drainage of hygromas and other extraventricular conditions. Burr Hole Reservoirs Hydrocephalus valve components are elements used in the implantation of hydrocephalus valve systems. In addition, the burr hole reservoir may be used in conjunction with a ventricular catheter to access ventricular CSF. Gravity Compensating Accessory The Gravity Compensating Accessory is an implantable device which is implanted in series with a hydrocephalus valve to control cerebrospinal fluid (CSF) drainage from the cerebral ventricles to an appropriate drainage site. It is designed to minimize the excessive reduction in intraventricular pressure (relative to atmosphere) and CSF volume caused by the "pull" exerted by the fluid column within the outflow catheter when the patient is sitting or standing.

Source page: https://510kreport.com/device/K152897
Methodology: https://510kreport.com/methodology