MTD — Catheter, Intracardiac Mapping, High-Density Array Class II
FDA Device Classification
Classification Details
- Product Code
- MTD
- Device Class
- Class II
- Regulation Number
- 870.1220
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253205 | cortex | OptiMap Catheter - 50mm (OPTI-CATH2-50) | March 13, 2026 |
| K233433 | medtronic | Sphere-9Dx Diagnostic Catheter (AFR-00009) | August 7, 2024 |
| K241372 | abbott medical | Advisor HD Grid X Mapping Catheter, Sensor Enabled | July 9, 2024 |
| K231312 | biosense webster | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webs | July 10, 2023 |
| K223666 | ablacon | Ablacath Mapping Catheter | March 17, 2023 |
| K230253 | biosense webster | OPTRELL Mapping Catheter with TRUEref Technology | March 2, 2023 |
| K210766 | acutus medical | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | June 21, 2022 |
| K211438 | biosense webster | OPTRELL Mapping Catheter with TRUEref Technology | March 18, 2022 |
| K201806 | sterilmed inc. (johnson and johnson) | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | June 23, 2021 |
| K201341 | acutus medical | AcQMap 3D Imaging and Mapping Catheter | September 15, 2020 |
| K200212 | innovative health | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | September 3, 2020 |
| K201750 | biosense webster | Pentaray Nav eco High-Density Mapping Catheter | August 6, 2020 |
| K193237 | biosense webster | Carto Octaray Mapping Catheter with Trueref Technology | July 31, 2020 |
| K172393 | st. jude medical | Advisor HD Grid Mapping Catheter, Sensor Enabled | April 23, 2018 |
| K170819 | acutus medical | AcQMap 3D Imaging and Mapping Catheter | October 16, 2017 |
| K163709 | abbott electrophysiology | FIRMap Catheter | February 28, 2017 |
| K153093 | abbott electrophysiology | FIRMap Catheter | April 7, 2016 |
| K142182 | topera | FRIMAP ADAPTER CONNECTOR (MAC) | September 9, 2014 |
| K140733 | boston scientific corporation | CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER | April 28, 2014 |
| K130827 | topera | FIRMAP CATHETER | October 31, 2013 |