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510(k) K150312

Vdrive system, Vdrive Duo, Vdrive with V-Sono by Stereotaxis, Inc. — Product Code DXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2015
Date Received
February 9, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Catheter Control, Steerable
Device Class
Class II
Regulation Number
870.1290
Review Panel
CV
Submission Type

Other clearances by Stereotaxis, Inc.

  • K251792 — Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (November 6, 2025)
  • K250590 — MAGiC Sweep™ EP Mapping Catheter (July 23, 2025)
  • K193147 — Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (March 5, 2020)
  • K192775 — Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Card (October 30, 2019)
  • K183027 — Steerable catheter control system (September 6, 2019)
  • K141530 — VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS (December 18, 2014)
  • K140804 — VDRIVE WITH V-LOOP/ VDRIVE DUO (September 3, 2014)
  • K133396 — VDRIVE WITH V-SONO (February 6, 2014)
  • K122659 — VDRIVE W/V-SONO (July 26, 2013)
  • K093092 — ODYSSEY WORKSTATION (January 21, 2010)

Other clearances for product code DXX

  • K251792 — Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (November 6, 2025)
  • K243789 — LIBERTY Endovascular Robotic System (LIBERTYOS) (September 4, 2025)
  • K221464 — CorPath GRX System (July 27, 2022)
  • K202275 — CorPath GRX System (December 11, 2020)
  • K180517 — CorPath GRX System (March 29, 2018)
  • K173806 — CorPath GRX System (March 1, 2018)
  • K173288 — CorPath GRX System (February 15, 2018)
  • K160121 — CorPath GRX System (October 27, 2016)
  • K152999 — CorPath 200 System (March 18, 2016)
  • K150892 — CorPath 200 System (October 2, 2015)