Product Code: DXX FDA class 2 21 CFR 870.1290

System, Catheter Control, Steerable

Cardiovascular

The Steerable Catheter Control System is a cardiovascular device used to guide and maneuver a catheter within the vascular system or heart chambers with greater precision, typically used during diagnostic or interventional cardiac procedures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DXX and the applicable regulation is 21 CFR 870.1290, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DXX
Device Class: FDA class 2
Regulation Number: 870.1290
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251792	Stereotaxis GenesisX RMN with Navigant Workstation (NWS)	Nov 06, 2025	Substantially Equivalent	Stereotaxis, Inc.
K243789	LIBERTY Endovascular Robotic System (LIBERTYOS)	Sep 04, 2025	Substantially Equivalent	Microbot Medical , Ltd.
K221464	CorPath GRX System	Jul 27, 2022	Substantially Equivalent	Corindus, Inc.
K202275	CorPath GRX System	Dec 11, 2020	Substantially Equivalent	Corindus, Inc.
K180517	CorPath GRX System	Mar 29, 2018	Substantially Equivalent	Corindus, Inc.
K173806	CorPath GRX System	Mar 01, 2018	Substantially Equivalent	Corindus, Inc.
K173288	CorPath GRX System	Feb 15, 2018	Substantially Equivalent	Corindus, Inc.
K160121	CorPath GRX System	Oct 27, 2016	Substantially Equivalent	Corindus, Inc.
K152999	CorPath 200 System	Mar 18, 2016	Substantially Equivalent	Corindus, Inc.
K150892	CorPath 200 System	Oct 02, 2015	Substantially Equivalent	Corindus, Inc.
K151730	Magellan Robotic System	Jul 23, 2015	Substantially Equivalent	Hansen Medical, Inc.
K143227	Magellan Robotic System, Magellan Robotic Catheter 10Fr	Jul 01, 2015	Substantially Equivalent	Hansen Medical, Inc.
K150312	Vdrive system, Vdrive Duo, Vdrive with V-Sono	Jun 17, 2015	Substantially Equivalent	Stereotaxis, Inc.
K141530	VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS	Dec 18, 2014	Substantially Equivalent	Stereotaxis, Inc.
K140804	VDRIVE WITH V-LOOP/ VDRIVE DUO	Sep 03, 2014	Substantially Equivalent	Stereotaxis, Inc.
K141614	MAGELLAN ROBOTIC SYSTEM	Aug 07, 2014	Substantially Equivalent	Hansen Medical
K141822	SENSEI X ROBOTIC CATHETER SYSTEM	Aug 05, 2014	Substantially Equivalent	Hanson Medical, Inc.
K132369	MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR	Sep 27, 2013	Substantially Equivalent	Hansen Medical, Inc.
K122488	AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES	Nov 20, 2012	Substantially Equivalent	Catheter Robotics, Inc.
K120834	CORPATH 200 SYSTEM	Jul 19, 2012	Substantially Equivalent	Corindus, Inc.
K113628	AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES	Jun 12, 2012	Substantially Equivalent	Catheter Robotics, Inc.
K111004	HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER	May 29, 2012	Substantially Equivalent	Hansen Medical, Inc.
K102168	SENSEI X ROBOTIC CATHETER SYSTEM	Oct 22, 2010	Substantially Equivalent	Hansen Medical, Inc.
K091808	SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057	Sep 10, 2009	Unknown	Hansen Medical, Inc.
K090365	HANSEN MEDICAL ARTISAN S CONTROL CATHETER	May 07, 2009	Unknown	Hansen Medical, Inc.
K073225	SENSEI CATHETER CONTROL SYSTEM	Jun 30, 2008	Unknown	Hansen Medical, Inc.
K072371	ODYSSEY WORKSTATION	Nov 14, 2007	Substantially Equivalent	Stereotaxis, Inc.
K052480	HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH	May 02, 2007	Unknown	Hansen Medical, Inc.
K051760	NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05	May 05, 2006	Substantially Equivalent	Stereotaxis, Inc.
K032937	NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500	Jul 01, 2004	Substantially Equivalent	Stereotaxis, Inc.
K021555	STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM	Jan 15, 2003	Substantially Equivalent	Stereotaxis, Inc.
K924125	CRI ELECTRONIC CONTROL SYSTEM	May 26, 1993	Substantially Equivalent	Catheter Research C/O Burditt, Bowles & Radzius
K904787	CRI STEERABLE CATHETER CONTROL SYSTEM	Dec 17, 1990	Substantially Equivalent	Catheter Research C/O Burditt, Bowles & Radzius