Cleared Traditional

K122488 - AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES

K122488 is an FDA 510(k) clearance for AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES, 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 97-day FDA review.

K122488 · Catheter Robotics, Inc. · Cardiovascular device
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Nov 2012
Decision
97d
Days
Class 2
Risk

K122488 is an FDA 510(k) clearance for the AMIGO REMOTE CATHETER SYSTEM & 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 November 20, 2012 after a review of 97 days - within the typical 510(k) review window.

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 - K122488

510(k) Number K122488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2012
Decision Date November 20, 2012
Days to Decision 97 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
28d faster than avg
Panel avg: 125d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

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 K122488.
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K132369 · Hansen Medical, Inc. · Sep 2013
CORPATH 200 SYSTEM
K120834 · Corindus, Inc. · Jul 2012
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
K113628 · Catheter Robotics, Inc. · Jun 2012
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
K111004 · Hansen Medical, Inc. · May 2012