# K983799: Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System Pole Clamp, Medtronic PS Medicl

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic PS Medical
- Decided: Jan 26, 1999 after 90 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- 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 K920156 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954021: External Drainage System (Eds and Eds II), Johnson & Johnson Professionals, Inc. (1995) Summary page 1.
- K920156: Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY, Clinical Neuro Systems, LLC (1992) Summary page 1.

## Most influential descendants
- K201118: Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level (2020), 0 descendants of its own

## Indications for use
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to 1. Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative; 2. Monitor CSF chemistry, cytology and physiology; 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with Severe head injury; Subarachnoid hemorrhage graded Ill, IV or V preoperatively; Reyes syndrome or similar encephalopathies; Hydrocephalus; Intracranial hemorrhage Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions.

Source page: https://510kreport.com/device/K983799
Methodology: https://510kreport.com/methodology