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510(k) K051760

NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 by Stereotaxis, Inc. — Product Code DXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2006
Date Received
June 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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.

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  • 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 DXX

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  • 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)