

# NPE · Material, Embolization, Neurovascular, Polymerizing Or Precipitating

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/NE-misc/NPE

## Overview

- **Product Code:** NPE
- **Device Name:** Material, Embolization, Neurovascular, Polymerizing Or Precipitating
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Life-sustaining:** yes

## Identification

This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation.  It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ.  Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

**Source:** [https://fda.innolitics.com/submissions/NE/NE-misc/NPE](https://fda.innolitics.com/submissions/NE/NE-misc/NPE)

**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
