DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording Class II
FDA product code DRF covers "Catheter, Electrode Recording, Or Probe, Electrode Recording", 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
- DRF
- 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 |
|---|---|---|---|
| K252794 | imricor medical systems | Vision-MR Diagnostic Catheter | January 8, 2026 |
| K250590 | stereotaxis | MAGiC Sweep EP Mapping Catheter | July 23, 2025 |
| K250310 | boston scientific corporation | VIKING Fixed Curve Diagnostic Catheter | June 27, 2025 |
| K240366 | boston scientific corporation | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional | November 1, 2024 |
| K233900 | synaptic medical corporation | Nordica PV Cryo Mapping Catheter | September 6, 2024 |
| K233397 | medtronic | Cosine-10TM Diagnostic Catheter | December 2, 2023 |
| K233207 | boston scientific corporation | Polaris X Unidirectional Steerable Diagnostic Catheter | October 27, 2023 |
| K232651 | boston scientific corporation | BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter | September 29, 2023 |
| K230503 | boston scientific | Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable | April 25, 2023 |
| K210313 | shanghai microport ep medtech co | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | December 30, 2022 |
| K220796 | boston scientific corporation | IntellaMap Orion High Resolution Mapping Catheter | June 10, 2022 |
| K203793 | synaptic medical corporation | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | February 14, 2022 |
| K211327 | cathrx | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiolog | February 10, 2022 |
| K211219 | biosense webster | LASSOSTAR NAV Circular Mapping Catheter | January 26, 2022 |
| K212593 | biotronick | ViaCath, AcQRate Dx Steerable Catheter | October 15, 2021 |
| K211494 | boston scientific corporation | Polaris X Unidirectional Steerable Diagnostic Catheter | September 14, 2021 |
| K211375 | boston scientific corporation | Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter | September 10, 2021 |
| K201445 | biotronik | MultiCath, AcQRate Dx Fixed Curve Catheter | September 2, 2021 |
| K203261 | innovative health | Reprocessed Inquiry Steerable Diagnostic EP Catheter | March 5, 2021 |
| K193632 | biosense webster | LassoStar Circular Mapping Catheter | June 30, 2020 |