DXX · Class II · 21 CFR 870.1290

FDA Product Code DXX: System, Catheter Control, Steerable

Leading manufacturers include Stereotaxis, Inc., Corindus, Inc. and Hansen Medical, Inc..

34
Total
34
Cleared
162d
Avg days
1990
Since
Growing category - 3 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 147d avg (recent)

FDA 510(k) Cleared System, Catheter Control, Steerable Devices (Product Code DXX)

34 devices
1–24 of 34
Cleared Aug 27, 2026
GenesisX RMN
K262744
Stereotaxis, Inc.
Cardiovascular · 24d
Cleared Nov 06, 2025
Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)
K251792
Stereotaxis, Inc.
Cardiovascular · 148d
Cleared Sep 04, 2025
LIBERTY Endovascular Robotic System (LIBERTYOS)
K243789
Microbot Medical , Ltd.
Cardiovascular · 269d
Cleared Jul 27, 2022
CorPath GRX System
K221464
Corindus, Inc.
Cardiovascular · 69d
Cleared Dec 11, 2020
CorPath GRX System
K202275
Corindus, Inc.
Cardiovascular · 122d
Cleared Mar 29, 2018
CorPath GRX System
K180517
Corindus, Inc.
Cardiovascular · 30d
Cleared Mar 01, 2018
CorPath GRX System
K173806
Corindus, Inc.
Cardiovascular · 76d
Cleared Feb 15, 2018
CorPath GRX System
K173288
Corindus, Inc.
Cardiovascular · 122d
Cleared Oct 27, 2016
CorPath GRX System
K160121
Corindus, Inc.
Cardiovascular · 282d
Cleared Mar 18, 2016
CorPath 200 System
K152999
Corindus, Inc.
Cardiovascular · 157d
Cleared Oct 02, 2015
CorPath 200 System
K150892
Corindus, Inc.
Cardiovascular · 183d
Cleared Jul 23, 2015
Magellan Robotic System
K151730
Hansen Medical, Inc.
Cardiovascular · 27d
Cleared Jul 01, 2015
Magellan Robotic System, Magellan Robotic Catheter 10Fr
K143227
Hansen Medical, Inc.
Cardiovascular · 233d
Cleared Jun 17, 2015
Vdrive system, Vdrive Duo, Vdrive with V-Sono
K150312
Stereotaxis, Inc.
Cardiovascular · 128d
Cleared Dec 18, 2014
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
K141530
Stereotaxis, Inc.
Cardiovascular · 192d
Cleared Sep 03, 2014
VDRIVE WITH V-LOOP/ VDRIVE DUO
K140804
Stereotaxis, Inc.
Cardiovascular · 156d
Cleared Aug 07, 2014
MAGELLAN ROBOTIC SYSTEM
K141614
Hansen Medical
Cardiovascular · 52d
Cleared Aug 05, 2014
SENSEI X ROBOTIC CATHETER SYSTEM
K141822
Hanson Medical, Inc.
Cardiovascular · 29d
Cleared Sep 27, 2013
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
K132369
Hansen Medical, Inc.
Cardiovascular · 59d
Cleared Nov 20, 2012
AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES
K122488
Catheter Robotics, Inc.
Cardiovascular · 97d
Cleared Jul 19, 2012
CORPATH 200 SYSTEM
K120834
Corindus, Inc.
Cardiovascular · 122d
Cleared Jun 12, 2012
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
K113628
Catheter Robotics, Inc.
Cardiovascular · 187d
Cleared May 29, 2012
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
K111004
Hansen Medical, Inc.
Cardiovascular · 414d
Cleared Nov 14, 2007
ODYSSEY WORKSTATION
K072371
Stereotaxis, Inc.
Cardiovascular · 83d

About Product Code DXX - Regulatory Context

510(k) Submission Activity

34 total 510(k) submissions under product code DXX since 1990, with 34 receiving FDA clearance (average review time: 162 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DXX Product Code

FDA review times for DXX submissions have been consistent, averaging 147 days recently vs 164 days historically.

DXX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →