MTD · Catheter, Intracardiac Mapping, High-Density Array
Cardiovascular · 21 CFR 870.1220 · Class 2
Overview
| Product Code | MTD |
|---|---|
| Device Name | Catheter, Intracardiac Mapping, High-Density Array |
| Regulation | 21 CFR 870.1220 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.
Classification Rationale
Class II (performance standards).
Cleared Devices (33)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. | Mar 13, 2026 | SESE |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | Medtronic | Aug 7, 2024 | SESE |
| K241372 | Advisor HD Grid X Mapping Catheter, Sensor Enabled | ABBOTT MEDICAL | Jul 9, 2024 | SESE |
| 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 | Biosense Webster, Inc. | Jul 10, 2023 | SESE |
| K223666 | Ablacath Mapping Catheter | Ablacon, Inc. | Mar 17, 2023 | SESE |
| K230253 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | Mar 2, 2023 | SESE |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | Acutus Medical, Inc. | Jun 21, 2022 | SESE |
| K211438 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | Mar 18, 2022 | SESE |
| K201806 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Sterilmed Inc. (Johnson and Johnson) | Jun 23, 2021 | SESE |
| K201341 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | Sep 15, 2020 | SESE |
| K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | Sep 3, 2020 | SESE |
| K201750 | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. | Aug 6, 2020 | SESE |
| K193237 | Carto Octaray Mapping Catheter with Trueref Technology | Biosense Webster, Inc. | Jul 31, 2020 | SESE |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | Apr 23, 2018 | SESE |
| K170819 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | Oct 16, 2017 | SESE |
| K163709 | FIRMap Catheter | Abbott Electrophysiology | Feb 28, 2017 | SESE |
| K153093 | FIRMap Catheter | Abbott Electrophysiology | Apr 7, 2016 | SESE |
| K142182 | FRIMAP ADAPTER CONNECTOR (MAC) | Topera, Inc. | Sep 9, 2014 | SESE |
| K140733 | CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER | Boston Scientific Corporation | Apr 28, 2014 | SESE |
| K130827 | FIRMAP CATHETER | Topera, Inc. | Oct 31, 2013 | SESE |
| K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | Biosense Webster, Inc. | Mar 5, 2013 | SESE |
| K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER | Biosense Webster, Inc. | May 24, 2012 | SESE |
| K121006 | ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER | St Jude Medical | May 3, 2012 | SESE |
| K050217 | FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) | Biosense Webster, Inc. | Mar 30, 2005 | SESE |
| K021232 | CONSTELLATION CATHETERS, MODEL 8031M | Boston Scientific Corp | May 16, 2002 | SESU |
| K012926 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 | Endocardial Solutions, Inc. | Sep 28, 2001 | SESU |
| K003782 | CONSTELLATION CATHETER, MODEL 8031 | Boston Scientific Corp | Feb 14, 2001 | SESU |
| K000277 | CONSTELLATION CATHETERS | Boston Scientific Corp | Sep 26, 2000 | SESE |
| K992777 | CONSTELLATION CATHETERS, MODEL 8039 | Boston Scientific Corp | Nov 12, 1999 | SESU |
| K990795 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES | Cardiac Pathways Corp. | Jun 8, 1999 | SESE |
| K983456 | ENSITE 3000 SYSTEM | Endocardial Solutions, Inc. | Apr 21, 1999 | SESU |
| K983171 | CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM | Boston Scientific Corp | Mar 11, 1999 | SESE |
| K982540 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT, | Cardiac Pathways Corp. | Jan 27, 1999 | SESU |
Top Applicants
- Biosense Webster, Inc. — 8 clearances
- Boston Scientific Corp — 5 clearances
- Acutus Medical, Inc. — 3 clearances
- Topera, Inc. — 2 clearances
- Endocardial Solutions, Inc. — 2 clearances
