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510(k) K122488

AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES by Catheter Robotics, Inc. — Product Code DXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2012
Date Received
August 15, 2012
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 Catheter Robotics, Inc.

  • DEN140009 — AMIGO REMOTE CATHETER SYSTEM (December 18, 2014)
  • K113628 — AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES (June 12, 2012)

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