← Product Code [LKG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LKG) · K874498

# CSF-VENTRICULOSTOMY RESERVOIR (K874498)

_Pudenz-Schulte Medical Research Corp. · LKG · Feb 11, 1988 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94neurological-therapeutic-devices/LKG/K874498

## Device Facts

- **Applicant:** Pudenz-Schulte Medical Research Corp.
- **Product Code:** [LKG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LKG.md)
- **Decision Date:** Feb 11, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5550
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94neurological-therapeutic-devices/LKG/K874498](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94neurological-therapeutic-devices/LKG/K874498)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com