Not Cleared Direct

DEN140009 - AMIGO REMOTE CATHETER SYSTEM (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN140009 · Catheter Robotics, Inc. · Cardiovascular device
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Dec 2014
Decision
303d
Days
Class 2
Risk

DEN140009 is an FDA 510(k) submission (not cleared) for the AMIGO REMOTE CATHETER SYSTEM. Classified as Catheter Remote Control System (product code PJB), Class II - Special Controls.

Submitted by Catheter Robotics, Inc. (Mt. Olive, US). The FDA issued a Not Cleared (DENG) decision on December 18, 2014 after a review of 303 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5700 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 303 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Catheter Robotics, Inc. devices

Submission Details

510(k) Number DEN140009 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 18, 2014
Decision Date December 18, 2014
Days to Decision 303 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 125d · This submission: 303d
Pathway characteristics

Device Classification

Product Code PJB Catheter Remote Control System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5700
Definition A Steerable Cardiac Ablation Catheter Remote Control System Is A Device That Is External To The Body And Interacts With The Manual Handle Of A Steerable Cardiac Ablation Catheter To Remotely Control The Advancement, Retraction, Rotation, And Deflection Of A Steerable Ablation Catheter Used For The Treatment Of Cardiac Arrhythmias In The Right Side Of The Heart. The Device Allows Reversion To Manual Control Of The Steerable Cardiac Ablation Catheter Without Withdrawal Of The Catheter And Interruption Of The Procedure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.