# K030289: Hermetic Plus External CSF Drainage Systems, Ins-8301,Ins-8302,Ins-8700, NL850-830N

- Pathway: 510(k) (Special)
- Applicant: Integra Lifesciences Corp.
- Decided: Feb 26, 2003 after 29 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: 2 generations back to K864676 (1986). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972994: External CSF Drainage Management Systems, Integra Neurocare, LLC (1997) Summary page 1.

## Most influential descendants
- 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
- K150898: LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm (2015), 0 descendants of its own

## Indications for use
The Hermetic Plu? External CSF Drainage System is indicated for draining and monitoring of Cerebrospinal Fluid (CSF) flow from the lateral ventricles of the brain or lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), monitor intracranial pressure (ICP), monitor cerebrospinal fluid (CSF), and provide temporary CSF drainage for patients with infected hydrocephalic shunts.

Source page: https://510kreport.com/device/K030289
Methodology: https://510kreport.com/methodology