Cleared Traditional

K193237 - Carto Octaray Mapping Catheter with Trueref Technology

K193237 is an FDA 510(k) clearance for Carto Octaray Mapping Catheter with Tru..., manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code MTD cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K193237 · Biosense Webster, Inc. · Cardiovascular device
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Jul 2020
Decision
249d
Days
Class 2
Risk

K193237 is an FDA 510(k) clearance for the Carto Octaray Mapping Catheter with Trueref Technology. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Irvin, US). The FDA issued a Cleared decision on July 31, 2020 after a review of 249 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 Biosense Webster, Inc. devices

FDA 510(k) Submission Details - K193237

510(k) Number K193237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2019
Decision Date July 31, 2020
Days to Decision 249 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
124d slower than avg
Panel avg: 125d · This submission: 249d
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 K193237.
AcQMap 3D Imaging and Mapping Catheter
K201341 · Acutus Medical, Inc. · Sep 2020
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
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