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510(k) K133396

VDRIVE WITH V-SONO by Stereotaxis, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2014
Date Received
November 6, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Stereotaxis, Inc.

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  • 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)
  • K122659 — VDRIVE W/V-SONO (July 26, 2013)
  • K093092 — ODYSSEY WORKSTATION (January 21, 2010)

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