Cleared Traditional

K153093 - FIRMap Catheter

K153093 is an FDA 510(k) clearance for FIRMap Catheter, manufactured by Abbott Electrophysiology. The device is a Class 2 Cardiovascular device with product code MTD cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K153093 · Abbott Electrophysiology · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
164d
Days
Class 2
Risk

K153093 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 April 7, 2016 after a review of 164 days - an extended review 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: 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 Abbott Electrophysiology devices

FDA 510(k) Submission Details - K153093

510(k) Number K153093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2015
Decision Date April 07, 2016
Days to Decision 164 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
39d slower than avg
Panel avg: 125d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MTD Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K153093.
Advisor HD Grid Mapping Catheter, Sensor Enabled
K172393 · St. Jude Medical, Inc. · Apr 2018
AcQMap 3D Imaging and Mapping Catheter
K170819 · Acutus Medical, Inc. · Oct 2017
FIRMap Catheter
K163709 · Abbott Electrophysiology · Feb 2017
FRIMAP ADAPTER CONNECTOR (MAC)
K142182 · Topera, Inc. · Sep 2014
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · Boston Scientific Corporation · Apr 2014
FIRMAP CATHETER
K130827 · Topera, Inc. · Oct 2013