Cleared Traditional

K163709 - FIRMap Catheter (FDA 510(k) Clearance)

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

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 33
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K163709.
OptiMap Catheter - 60mm (OPTI-CATH2-60)
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OptiMap Catheter - 50mm (OPTI-CATH2-50)
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Sphere-9Dx Diagnostic Catheter (AFR-00009)
K233433 · Medtronic · Aug 2024
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
K241372 · Abbott Medical · Jul 2024
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
K231312 · Biosense Webster, Inc. · Jul 2023
OPTRELL™ Mapping Catheter with TRUEref™ Technology
K230253 · Biosense Webster, Inc. · Mar 2023