Catheter, Intracardiac Mapping, High-Density Array
FDA product code MTD · Class II (moderate risk) · 21 CFR 870.1220 · Cardiovascular
34510(k) clearances
0PMA approvals
8recalls
Manufacturers
- Biosense Webster, Inc. 8
- Boston Scientific Corporation 6
- Acutus Medical, Inc. 3
- Cardiac Pathways Corp. 2
- Endocardial Solutions, Inc. 2
- St Jude Medical 2
- Topera, Inc. 2
- Abbott Electrophysiology 2
- Cortex, Inc. 2
- Innovative Health, LLC 1
- Sterilmed Inc. (Johnson and Johnson) 1
- Ablacon, Inc. 1
- Abbott Medical 1
- Medtronic, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60)MTD · Special | Cortex, Inc. | 04/23/2026SE |
| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50)MTD · Traditional | Cortex, Inc. | 03/13/2026SE |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009)MTD · Traditional | Medtronic | 08/07/2024SE |
| K241372 | Advisor HD Grid X Mapping Catheter, Sensor EnabledMTD · Special | Abbott Medical | 07/09/2024SE |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…MTD · Special | Biosense Webster, Inc. | 07/10/2023SE |
| K223666 | Ablacath Mapping CatheterMTD · Traditional | Ablacon, Inc. | 03/17/2023SE |
| K230253 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Special | Biosense Webster, Inc. | 03/02/2023SE |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009MTD · Traditional | Acutus Medical, Inc. | 06/21/2022SE |
| K211438 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Traditional | Biosense Webster, Inc. | 03/18/2022SE |
| K201806 | Reprocessed PentaRay Nav eco High-Density Mapping CatheterMTD · Traditional | Sterilmed Inc. (Johnson and Johnson) | 06/23/2021SE |
| K201341 | AcQMap 3D Imaging and Mapping CatheterMTD · Traditional | Acutus Medical, Inc. | 09/15/2020SE |
| K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledMTD · Traditional | Innovative Health, LLC | 09/03/2020SE |
| K201750 | Pentaray Nav eco High-Density Mapping CatheterMTD · Traditional | Biosense Webster, Inc. | 08/06/2020SE |
| K193237 | Carto Octaray Mapping Catheter with Trueref TechnologyMTD · Traditional | Biosense Webster, Inc. | 07/31/2020SE |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor EnabledMTD · Traditional | St. Jude Medical, Inc. | 04/23/2018SE |
| K170819 | AcQMap 3D Imaging and Mapping CatheterMTD · Traditional | Acutus Medical, Inc. | 10/16/2017SE |
| K163709 | FIRMap CatheterMTD · Traditional | Abbott Electrophysiology | 02/28/2017SE |
| K153093 | FIRMap CatheterMTD · Traditional | Abbott Electrophysiology | 04/07/2016SE |
| K142182 | Frimap Adapter Connector (Mac)MTD · Special | Topera, Inc. | 09/09/2014SE |
| K140733 | Constellation Multiple Electrode Recording & Pacing CatheterMTD · Traditional | Boston Scientific Corporation | 04/28/2014SE |
| K130827 | Firmap CatheterMTD · Traditional | Topera, Inc. | 10/31/2013SE |
| K123837 | Pentaray Nav Eco High-Density Mapping CatheterMTD · Special | Biosense Webster, Inc. | 03/05/2013SE |
| K120425 | Pentaray Nav High-Density Mapping CatheterMTD · Traditional | Biosense Webster, Inc. | 05/24/2012SE |
| K121006 | Ensite Array Multi-Electrode Diagnostic CatheterMTD · Special | St Jude Medical | 05/03/2012SE |
| K050217 | Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode…MTD · Traditional | Biosense Webster, Inc. | 03/30/2005SE |
| K021232 | Constellation Catheters, Model 8031MMTD · Special | Boston Scientific Corp | 05/16/2002SESU |
| K012926 | Modification to Ensite 3000 System, Model EE3000MTD · Special | Endocardial Solutions, Inc. | 09/28/2001SESU |
| K003782 | Constellation Catheter, Model 8031MTD · Special | Boston Scientific Corp | 02/14/2001SESU |
| K000277 | Constellation CathetersMTD · Special | Boston Scientific Corp | 09/26/2000SE |
| K992777 | Constellation Catheters, Model 8039MTD · Special | Boston Scientific Corp | 11/12/1999SESU |
| K990795 | Mercator Atrial High Density Array Catheter; Cardiac Pathways Egm Adapter CablesMTD · Traditional | Cardiac Pathways Corp. | 06/08/1999SE |
| K983456 | Ensite 3000 SystemMTD · Traditional | Endocardial Solutions, Inc. | 04/21/1999SESU |
| K983171 | Constellation Multiple Electrode Pacing and Recording SystemMTD · Traditional | Boston Scientific Corp | 03/11/1999SE |
| K982540 | Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial…MTD · Traditional | Cardiac Pathways Corp. | 01/27/1999SESU |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1213-2022 Class II | FIRMap" Catheter, 60mm BasketIncorrect product labeling. | Abbott | 04/28/2022Terminated |
| Z-2371-2020 Class II | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product…Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to… | Biosense Webster | 04/22/2020Terminated |
| Z-0212-2018 Class II | PENTARAY NAV High-Density Mapping Catheter.Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters… | Biosense Webster, Inc. | 05/17/2017Terminated |
| Z-0211-2018 Class II | PENTARAY NAV High-Density Mapping Catheter.Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters… | Biosense Webster, Inc. | 05/17/2017Terminated |
| Z-1591-2016 Class II | Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209…Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the… | Biosense Webster, Inc. | 04/14/2016Terminated |
| Z-1590-2016 Class II | Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203…Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the… | Biosense Webster, Inc. | 04/14/2016Terminated |
| Z-2478-2015 Class III | FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F…The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to… | Abbott Electrophysiology | 08/12/2015Terminated |
| Z-1176-2014 Class II | PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No.…Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip… | Biosense Webster, Inc. | 02/20/2014Terminated |