Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3955](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3955) → QWA — Cardiovascular Delivery Catheter System Positioning And Stabilization Device

# QWA · Cardiovascular Delivery Catheter System Positioning And Stabilization Device

_Cardiovascular · 21 CFR 870.3955 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/QWA

## Overview

- **Product Code:** QWA
- **Device Name:** Cardiovascular Delivery Catheter System Positioning And Stabilization Device
- **Regulation:** [21 CFR 870.3955](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3955)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A cardiovascular delivery catheter system positioning and stabilization device is a platform device or a part of a platform device that aids the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures (e.g., transcatheter valvular interventions). The device only provides mechanical support and does not include any electrical or robotic components. The device may be for single use or reusable.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/QWA](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/QWA)

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