Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1280](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1280) → DRA — Catheter, Steerable

# DRA · Catheter, Steerable

_Cardiovascular · 21 CFR 870.1280 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/DRA

## Overview

- **Product Code:** DRA
- **Device Name:** Catheter, Steerable
- **Regulation:** [21 CFR 870.1280](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1280)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 41)

Showing 20 most recent of 41 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250529](/device/K250529.md) | Globe Introducer (601-01001) | Kardium, Inc. | Jun 3, 2025 | SESE |
| [K233248](/device/K233248.md) | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | Dec 11, 2023 | SESE |
| [K232321](/device/K232321.md) | FlexCath Contour™ Steerable Sheath | Medtronic, Inc. | Oct 31, 2023 | SESE |
| [K223824](/device/K223824.md) | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor | Boston Scientific Corporation | Mar 22, 2023 | SESE |
| [K221397](/device/K221397.md) | MitraClip G4 Steerable Guide Catheter | ABBOTT MEDICAL | Sep 28, 2022 | SESE |
| [K221044](/device/K221044.md) | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | May 5, 2022 | SESE |
| [K211100](/device/K211100.md) | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | May 14, 2021 | SESE |
| [K202620](/device/K202620.md) | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | Nov 13, 2020 | SESE |
| [K192422](/device/K192422.md) | Steerable Introducer 12F | Freudenberg Medical, LLC | Oct 4, 2019 | SESE |
| [K190167](/device/K190167.md) | MitraClip G4 Steerable Guide Catheter | Abbott | May 29, 2019 | SESE |
| [K183174](/device/K183174.md) | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | Nov 26, 2018 | SESE |
| [K172394](/device/K172394.md) | Steerable Guide Catheter | Abbott Vascular | Sep 6, 2017 | SESE |
| [K162925](/device/K162925.md) | AcQGuide Steerable Sheath | Acutus Medical, Inc. | Apr 6, 2017 | SESE |
| [K160919](/device/K160919.md) | Hansen Medical Magellan Robotic Catheter 9Fr | Hansen Medical, Inc. | Sep 20, 2016 | SESE |
| [K161985](/device/K161985.md) | Steerable Guide Catheter | Abbott Vascular | Aug 7, 2016 | SESE |
| [K152310](/device/K152310.md) | HeartLight Deflectable Sheath | Cardiofocus, Inc. | Feb 24, 2016 | SESE |
| [K153304](/device/K153304.md) | Hansen Medical Magellan Robotic Catheter eKit | Hansen Medical, Inc. | Feb 1, 2016 | SESE |
| [K151463](/device/K151463.md) | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | Hansen Medical, Inc. | Aug 18, 2015 | SESE |
| [K133552](/device/K133552.md) | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT | Hansen Medical | Feb 7, 2014 | SESE |
| [K123591](/device/K123591.md) | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | Medtronic Cryocath, LP | Dec 27, 2012 | SESE |

## Top Applicants

- Catheter Research C/O Burditt, Bowles & Radzius — 4 clearances
- Evalve, Inc. — 4 clearances
- Medtronic Cryocath, LP — 4 clearances
- Abbott Vascular — 3 clearances
- Acutus Medical, Inc. — 3 clearances

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**Source:** [https://fda.innolitics.com/productcode/DRA](https://fda.innolitics.com/productcode/DRA)

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