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DXX — System, Catheter Control, Steerable Class II

FDA Device Classification

FDA product code DXX covers "System, Catheter Control, Steerable", a Class II medical device regulated under 21 CFR 870.1290. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DXX
Device Class
Class II
Regulation Number
870.1290
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251792stereotaxisStereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)November 6, 2025
K243789microbot medicalLIBERTY Endovascular Robotic System (LIBERTYOS)September 4, 2025
K221464corindusCorPath GRX SystemJuly 27, 2022
K202275corindusCorPath GRX SystemDecember 11, 2020
K180517corindusCorPath GRX SystemMarch 29, 2018
K173806corindusCorPath GRX SystemMarch 1, 2018
K173288corindusCorPath GRX SystemFebruary 15, 2018
K160121corindusCorPath GRX SystemOctober 27, 2016
K152999corindusCorPath 200 SystemMarch 18, 2016
K150892corindusCorPath 200 SystemOctober 2, 2015
K151730hansen medicalMagellan Robotic SystemJuly 23, 2015
K143227hansen medicalMagellan Robotic System, Magellan Robotic Catheter 10FrJuly 1, 2015
K150312stereotaxisVdrive system, Vdrive Duo, Vdrive with V-SonoJune 17, 2015
K141530stereotaxisVDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CASDecember 18, 2014
K140804stereotaxisVDRIVE WITH V-LOOP/ VDRIVE DUOSeptember 3, 2014
K141614hansen medicalMAGELLAN ROBOTIC SYSTEMAugust 7, 2014
K141822hanson medicalSENSEI X ROBOTIC CATHETER SYSTEMAugust 5, 2014
K132369hansen medicalMAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FRSeptember 27, 2013
K122488catheter roboticsAMIGO REMOTE CATHETER SYSTEM & ACCESSORIESNovember 20, 2012
K120834corindusCORPATH 200 SYSTEMJuly 19, 2012

FDA data resources