Cleared Traditional

K163709 - FIRMap Catheter

K163709 is the FDA 510(k) clearance for FIRMap Catheter by Abbott Electrophysiology. It is a Class 2 Cardiovascular device (product code MTD) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K163709 · Abbott Electrophysiology · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
60d
Days
Class 2
Risk

K163709 is an FDA 510(k) clearance for the FIRMap Catheter. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Abbott Electrophysiology (Menlo Park, US). The FDA issued a Cleared decision on February 28, 2017 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Electrophysiology devices

Submission Details

510(k) Number K163709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2016
Decision Date February 28, 2017
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MTD Catheter, Intracardiac Mapping, High-density Array
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - MTD Catheter, Intracardiac Mapping, High-density Array

All 25
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K163709.
Pentaray Nav eco High-Density Mapping Catheter
K201750 · Biosense Webster, Inc. · Aug 2020
Carto Octaray Mapping Catheter with Trueref Technology
K193237 · Biosense Webster, Inc. · Jul 2020
Advisor HD Grid Mapping Catheter, Sensor Enabled
K172393 · St. Jude Medical, Inc. · Apr 2018
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · Boston Scientific Corporation · Apr 2014
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
K123837 · Biosense Webster, Inc. · Mar 2013
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
K120425 · Biosense Webster, Inc. · May 2012