Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1290](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1290) → NDQ — System, Catheter Or Guidewire, Steerable (Magnetic)

# NDQ · System, Catheter Or Guidewire, Steerable (Magnetic)

_Cardiovascular · 21 CFR 870.1290 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NDQ

## Overview

- **Product Code:** NDQ
- **Device Name:** System, Catheter Or Guidewire, Steerable (Magnetic)
- **Regulation:** [21 CFR 870.1290](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1290)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K060967](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NDQ/K060967.md) | NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION | Stereotaxis, Inc. | Oct 19, 2006 | SESE |
| [K051373](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NDQ/K051373.md) | CRONUS GUIDEWIRE, MODEL 001-001470-1 | Stereotaxis, Inc. | Dec 9, 2005 | SESE |

## Top Applicants

- Stereotaxis, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NDQ](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NDQ)

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