Cleared Traditional

K113628 - AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES

K113628 is an FDA 510(k) clearance for AMIGO REMOTE CATHETER SYSTEM (RCS) & AC..., manufactured by Catheter Robotics, Inc.. The device is a Class 2 Cardiovascular device with product code DXX cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K113628 · Catheter Robotics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
187d
Days
Class 2
Risk

K113628 is an FDA 510(k) clearance for the AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES. Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Catheter Robotics, Inc. (Mount Olive, US). The FDA issued a Cleared decision on June 12, 2012 after a review of 187 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Catheter Robotics, Inc. devices

FDA 510(k) Submission Details - K113628

510(k) Number K113628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2011
Decision Date June 12, 2012
Days to Decision 187 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

DXX Device Classification - Class 2, Special Controls

Product Code DXX System, Catheter Control, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01139814 Completed Interventional Industry-sponsored

Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies

Clinical Study to Evaluate the Effectiveness and Safety of the Catheter Robotics Amigo Remote Catheter System for Performing Right-Sided Electrophysiology Mapping Studies

181
Patients (actual)
12
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Atrial Flutter; Ventricular Tachycardia
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Catheter Robotics, Inc. (industry)
Started 2010-06-01 → Primary completion 2011-10-01
Primary outcome
Navigation Performance
View full study on ClinicalTrials.gov

Regulatory Peers - DXX System, Catheter Control, Steerable

All 26
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K113628.
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
K132369 · Hansen Medical, Inc. · Sep 2013
AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES
K122488 · Catheter Robotics, Inc. · Nov 2012
CORPATH 200 SYSTEM
K120834 · Corindus, Inc. · Jul 2012
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
K111004 · Hansen Medical, Inc. · May 2012
ODYSSEY WORKSTATION
K072371 · Stereotaxis, Inc. · Nov 2007
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05
K051760 · Stereotaxis, Inc. · May 2006