Product code DXX— Cardiovascular

FDA has cleared 34 devices under product code DXX between 1990 and 2026, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20252 clearances
• 20221 clearance
• 20201 clearance
• 20183 clearances
• 20162 clearances
• 20154 clearances
• 20144 clearances
• 20131 clearance
• 20124 clearances
• 20101 clearance
• 20092 clearances
• 20081 clearance
• 20072 clearances
• 20061 clearance

• Stereotaxis, Inc.9 clearances
• Hansen Medical, Inc.9 clearances
• Corindus, Inc.9 clearances
• Catheter Robotics, Inc.2 clearances
• Catheter Research C/O Burditt, Bowles & Radzius2 clearances
• Microbot Medical , Ltd.1 clearance
• Hanson Medical, Inc.1 clearance
• Hansen Medical1 clearance

• K262744 — GenesisX RMNStereotaxis, Inc.·2026-08-27
• K251792 — Stereotaxis GenesisX RMN with Navigant Workstation (NWS)Stereotaxis, Inc.·2025-11-06
• K243789 — LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical , Ltd.·2025-09-04
• K221464 — CorPath GRX SystemCorindus, Inc.·2022-07-27
• K202275 — CorPath GRX SystemCorindus, Inc.·2020-12-11
• K180517 — CorPath GRX SystemCorindus, Inc.·2018-03-29
• K173806 — CorPath GRX SystemCorindus, Inc.·2018-03-01
• K173288 — CorPath GRX SystemCorindus, Inc.·2018-02-15
• K160121 — CorPath GRX SystemCorindus, Inc.·2016-10-27
• K152999 — CorPath 200 SystemCorindus, Inc.·2016-03-18
• K150892 — CorPath 200 SystemCorindus, Inc.·2015-10-02
• K151730 — Magellan Robotic SystemHansen Medical, Inc.·2015-07-23
• K143227 — Magellan Robotic System, Magellan Robotic Catheter 10FrHansen Medical, Inc.·2015-07-01
• K150312 — Vdrive system, Vdrive Duo, Vdrive with V-SonoStereotaxis, Inc.·2015-06-17
• K141530 — VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CASStereotaxis, Inc.·2014-12-18
• K140804 — VDRIVE WITH V-LOOP/ VDRIVE DUOStereotaxis, Inc.·2014-09-03
• K141614 — MAGELLAN ROBOTIC SYSTEMHansen Medical·2014-08-07
• K141822 — SENSEI X ROBOTIC CATHETER SYSTEMHanson Medical, Inc.·2014-08-05
• K132369 — MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FRHansen Medical, Inc.·2013-09-27
• K122488 — AMIGO REMOTE CATHETER SYSTEM & ACCESSORIESCatheter Robotics, Inc.·2012-11-20
• K120834 — CORPATH 200 SYSTEMCorindus, Inc.·2012-07-19
• K113628 — AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIESCatheter Robotics, Inc.·2012-06-12
• K111004 — HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETERHansen Medical, Inc.·2012-05-29
• K102168 — SENSEI X ROBOTIC CATHETER SYSTEMHansen Medical, Inc.·2010-10-22
• K091808 — SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057Hansen Medical, Inc.·2009-09-10
• K090365 — HANSEN MEDICAL ARTISAN S CONTROL CATHETERHansen Medical, Inc.·2009-05-07
• K073225 — SENSEI CATHETER CONTROL SYSTEMHansen Medical, Inc.·2008-06-30
• K072371 — ODYSSEY WORKSTATIONStereotaxis, Inc.·2007-11-14
• K052480 — HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATHHansen Medical, Inc.·2007-05-02
• K051760 — NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05Stereotaxis, Inc.·2006-05-05
• K032937 — NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500Stereotaxis, Inc.·2004-07-01
• K021555 — STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEMStereotaxis, Inc.·2003-01-15
• K924125 — CRI ELECTRONIC CONTROL SYSTEMCatheter Research C/O Burditt, Bowles & Radzius·1993-05-26
• K904787 — CRI STEERABLE CATHETER CONTROL SYSTEMCatheter Research C/O Burditt, Bowles & Radzius·1990-12-17