Cleared Traditional

K122488 - AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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.