MTD — Catheter, Intracardiac Mapping, High-Density Array Class II
FDA product code MTD covers "Catheter, Intracardiac Mapping, High-Density Array", a Class II medical device regulated under 21 CFR 870.1220. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261012 | cortex | OptiMap Catheter - 60mm (OPTI-CATH2-60) | April 23, 2026 |
| 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 |