# K972994: External CSF Drainage Management Systems

- Pathway: 510(k) (Traditional)
- Applicant: Integra Neurocare, LLC
- Decided: Nov 3, 1997 after 83 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 K864676 (1986). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932769: Camino Ventricular Drainage System, Camino Laboratories, Inc. (1995) Summary page 1.
- K864676: Heyer-Schulte Hermetic External CSF Drain. System, American V. Mueller (1986) Summary page 1.
- (no number) P-S Medical Becker External Drainage and Monitoring System: named in the summary without a submission number
- (no number) Codman External Drainage System I: named in the summary without a submission number

## Most influential descendants
- K030289: Hermetic Plus External CSF Drainage Systems, Ins-8301,Ins-8302,Ins-8700, NL850-830N (2003), 2 descendants of its own
- K121248: Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM) Safety Cushion for Tubing Set Attac (2013), 1 descendant of its own
- K170599: SureFlo EVD Catheter (2017), 0 descendants of its own
- K150898: LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm (2015), 0 descendants of its own
- K022638: Neurorecovery Ventricular Catheter & Main Valve Assembly Kit (2002), 0 descendants of its own

## Indications for use
The major indication for use of the External CSF Drainage Management Systems is the management of hydrocephalic shunt infections. If an internal shunt is not indicated, treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring may also require external drainage to control increased intracranial pressure. This device should only be used by a physician or qualified personnel under the direction of a physician. Care must be taken to ensure compliance with the manufacturer's instructions for use.

Source page: https://510kreport.com/device/K972994
Methodology: https://510kreport.com/methodology