Product Code: MTD FDA class 2 21 CFR 870.1220

Catheter, Intracardiac Mapping, High-Density Array

Cardiovascular

A High-Density Array Intracardiac Mapping Catheter is an electrophysiology catheter equipped with multiple closely spaced electrodes that is introduced into the heart to create detailed electrical maps of cardiac tissue, enabling precise identification of arrhythmia substrates for ablation therapy. It is FDA Class 2, requiring 510(k) clearance, with product code MTD under 21 CFR 870.1220 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MTD
Device Class: FDA class 2
Regulation Number: 870.1220
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

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GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 34 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261012	OptiMap Catheter - 60mm (OPTI-CATH2-60)	Apr 23, 2026	Substantially Equivalent	Cortex, Inc.
K253205	OptiMap Catheter - 50mm (OPTI-CATH2-50)	Mar 13, 2026	Substantially Equivalent	Cortex, Inc.
K233433	Sphere-9Dx Diagnostic Catheter (AFR-00009)	Aug 07, 2024	Substantially Equivalent	Medtronic
K241372	Advisor HD Grid X Mapping Catheter, Sensor Enabled	Jul 09, 2024	Substantially Equivalent	ABBOTT MEDICAL
K231312	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	Jul 10, 2023	Substantially Equivalent	Biosense Webster, Inc.
K223666	Ablacath Mapping Catheter	Mar 17, 2023	Substantially Equivalent	Ablacon, Inc.
K230253	OPTRELL Mapping Catheter with TRUEref Technology	Mar 02, 2023	Substantially Equivalent	Biosense Webster, Inc.
K210766	AcQMap 3D Imaging and Mapping Catheter, Model 900009	Jun 21, 2022	Substantially Equivalent	Acutus Medical, Inc.
K211438	OPTRELL Mapping Catheter with TRUEref Technology	Mar 18, 2022	Substantially Equivalent	Biosense Webster, Inc.
K201806	Reprocessed PentaRay Nav eco High-Density Mapping Catheter	Jun 23, 2021	Substantially Equivalent	Sterilmed Inc. (Johnson and Johnson)
K201341	AcQMap 3D Imaging and Mapping Catheter	Sep 15, 2020	Substantially Equivalent	Acutus Medical, Inc.
K200212	Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled	Sep 03, 2020	Substantially Equivalent	Innovative Health, LLC
K201750	Pentaray Nav eco High-Density Mapping Catheter	Aug 06, 2020	Substantially Equivalent	Biosense Webster, Inc.
K193237	Carto Octaray Mapping Catheter with Trueref Technology	Jul 31, 2020	Substantially Equivalent	Biosense Webster, Inc.
K172393	Advisor HD Grid Mapping Catheter, Sensor Enabled	Apr 23, 2018	Substantially Equivalent	St. Jude Medical, Inc.
K170819	AcQMap 3D Imaging and Mapping Catheter	Oct 16, 2017	Substantially Equivalent	Acutus Medical, Inc.
K163709	FIRMap Catheter	Feb 28, 2017	Substantially Equivalent	Abbott Electrophysiology
K153093	FIRMap Catheter	Apr 07, 2016	Substantially Equivalent	Abbott Electrophysiology
K142182	FRIMAP ADAPTER CONNECTOR (MAC)	Sep 09, 2014	Substantially Equivalent	Topera, Inc.
K140733	CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER	Apr 28, 2014	Substantially Equivalent	Boston Scientific Corporation
K130827	FIRMAP CATHETER	Oct 31, 2013	Substantially Equivalent	Topera, Inc.
K123837	PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER	Mar 05, 2013	Substantially Equivalent	Biosense Webster, Inc.
K120425	PENTARAY NAV HIGH-DENSITY MAPPING CATHETER	May 24, 2012	Substantially Equivalent	Biosense Webster, Inc.
K121006	ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER	May 03, 2012	Substantially Equivalent	St Jude Medical
K050217	FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)	Mar 30, 2005	Substantially Equivalent	Biosense Webster, Inc.
K021232	CONSTELLATION CATHETERS, MODEL 8031M	May 16, 2002	Unknown	Boston Scientific Corp
K012926	MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000	Sep 28, 2001	Unknown	Endocardial Solutions, Inc.
K003782	CONSTELLATION CATHETER, MODEL 8031	Feb 14, 2001	Unknown	Boston Scientific Corp
K000277	CONSTELLATION CATHETERS	Sep 26, 2000	Substantially Equivalent	Boston Scientific Corp
K992777	CONSTELLATION CATHETERS, MODEL 8039	Nov 12, 1999	Unknown	Boston Scientific Corp
K990795	MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES	Jun 08, 1999	Substantially Equivalent	Cardiac Pathways Corp.
K983456	ENSITE 3000 SYSTEM	Apr 21, 1999	Unknown	Endocardial Solutions, Inc.
K983171	CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM	Mar 11, 1999	Substantially Equivalent	Boston Scientific Corp
K982540	MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,	Jan 27, 1999	Unknown	Cardiac Pathways Corp.