Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5150](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5150) → PAV — Catheter, Neuro-Vasculature, Occluding Balloon

# PAV · Catheter, Neuro-Vasculature, Occluding Balloon

_Neurology · 21 CFR 882.5150 · Class f_

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

## Overview

- **Product Code:** PAV
- **Device Name:** Catheter, Neuro-Vasculature, Occluding Balloon
- **Regulation:** [21 CFR 882.5150](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5150)
- **Device Class:** f
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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