Cleared Traditional

Advisor HD Grid Mapping Catheter, Sensor Enabled (K172393) - FDA 510(k) Clearance

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

K172393 · St. Jude Medical, Inc. · Cardiovascular device
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Apr 2018
Decision
258d
Days
Class 2
Risk

K172393 is an FDA 510(k) clearance for the Advisor HD Grid Mapping Catheter, Sensor Enabled. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by St. Jude Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 23, 2018 after a review of 258 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 St. Jude Medical, Inc. devices

Submission Details

510(k) Number K172393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2017
Decision Date April 23, 2018
Days to Decision 258 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
133d slower than avg
Panel avg: 125d · This submission: 258d
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 21
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K172393.
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K200212 · Innovative Health, LLC · Sep 2020
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
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · Boston Scientific Corporation · Apr 2014
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
K121006 · St Jude Medical · May 2012
CONSTELLATION CATHETERS, MODEL 8031M
K021232 · Boston Scientific Corp · May 2002