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510(k) K060967

NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION by Stereotaxis, Inc. — Product Code NDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2006
Date Received
April 7, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Catheter Or Guidewire, Steerable (Magnetic)
Device Class
Class II
Regulation Number
870.1290
Review Panel
NE
Submission Type

Other clearances by Stereotaxis, Inc.

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  • 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)
  • K150312 — Vdrive system, Vdrive Duo, Vdrive with V-Sono (June 17, 2015)
  • 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)

Other clearances for product code NDQ

  • K051373 — CRONUS GUIDEWIRE, MODEL 001-001470-1 (December 9, 2005)