Panels › Cardiovascular › Product code MTD · Class 2
Catheter, Intracardiac Mapping, High-Density Array
Regulation 870.1220
2510(k)s in 12 months (34 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in MTD
| Company | 510(k)s | Recalls |
|---|---|---|
| Biosense Webster, Inc. | 8 | 6 |
| Boston Scientific Corp | 6 | 1 |
| Abbott Electrophysiology | 2 | 1 |
| Acutus Medical, Inc. | 3 | 0 |
| Cardiac Pathways Corp. | 2 | 0 |
| Cortex, Inc. | 2 | 0 |
| Endocardial Solutions, Inc. | 2 | 0 |
| St Jude Medical | 2 | 0 |
| Topera, Inc. | 2 | 0 |
| Abbott | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 23, 2026 | K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60) Cortex, Inc. | MTD |
| Mar 13, 2026 | K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50) Cortex, Inc. | MTD |
| Aug 7, 2024 | K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) Medtronic | MTD |
| Jul 9, 2024 | K241372 | Advisor HD Grid X Mapping Catheter, Sensor Enabled ABBOTT MEDICAL | MTD |
| Jul 10, 2023 | K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® Biosense Webster, Inc. | MTD |
| Mar 17, 2023 | K223666 | Ablacath Mapping Catheter Ablacon, Inc. | MTD |
| Mar 2, 2023 | K230253 | OPTRELL Mapping Catheter with TRUEref Technology Biosense Webster, Inc. | MTD |
| Jun 21, 2022 | K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 Acutus Medical, Inc. | MTD |
| Mar 18, 2022 | K211438 | OPTRELL Mapping Catheter with TRUEref Technology Biosense Webster, Inc. | MTD |
| Jun 23, 2021 | K201806 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter Sterilmed Inc. (Johnson and Johnson) | MTD |
| Sep 15, 2020 | K201341 | AcQMap 3D Imaging and Mapping Catheter Acutus Medical, Inc. | MTD |
| Sep 3, 2020 | K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled Innovative Health, LLC | MTD |
| Aug 6, 2020 | K201750 | Pentaray Nav eco High-Density Mapping Catheter Biosense Webster, Inc. | MTD |
| Jul 31, 2020 | K193237 | Carto Octaray Mapping Catheter with Trueref Technology Biosense Webster, Inc. | MTD |
| Apr 23, 2018 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled St. Jude Medical, Inc. | MTD |
| Oct 16, 2017 | K170819 | AcQMap 3D Imaging and Mapping Catheter Acutus Medical, Inc. | MTD |
| Feb 28, 2017 | K163709 | FIRMap Catheter Abbott Electrophysiology | MTD |
| Apr 7, 2016 | K153093 | FIRMap Catheter Abbott Electrophysiology | MTD |
| Sep 9, 2014 | K142182 | FRIMAP ADAPTER CONNECTOR (MAC) Topera, Inc. | MTD |
| Apr 28, 2014 | K140733 | CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER Boston Scientific Corporation | MTD |
| Oct 31, 2013 | K130827 | FIRMAP CATHETER Topera, Inc. | MTD |
| Mar 5, 2013 | K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER Biosense Webster, Inc. | MTD |
| May 24, 2012 | K120425 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER Biosense Webster, Inc. | MTD |
| May 3, 2012 | K121006 | ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER St Jude Medical | MTD |
| Mar 30, 2005 | K050217 | FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) Biosense Webster, Inc. | MTD |
| May 16, 2002 | K021232 | CONSTELLATION CATHETERS, MODEL 8031M Boston Scientific Corp | MTD |
| Sep 28, 2001 | K012926 | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 Endocardial Solutions, Inc. | MTD |
| Feb 14, 2001 | K003782 | CONSTELLATION CATHETER, MODEL 8031 Boston Scientific Corp | MTD |
| Sep 26, 2000 | K000277 | CONSTELLATION CATHETERS Boston Scientific Corp | MTD |
| Nov 12, 1999 | K992777 | CONSTELLATION CATHETERS, MODEL 8039 Boston Scientific Corp | MTD |
| Jun 8, 1999 | K990795 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES Cardiac Pathways Corp. | MTD |
| Apr 21, 1999 | K983456 | ENSITE 3000 SYSTEM Endocardial Solutions, Inc. | MTD |
| Mar 11, 1999 | K983171 | CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM Boston Scientific Corp | MTD |
| Jan 27, 1999 | K982540 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT, Cardiac Pathways Corp. | MTD |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.