DRF
- Product code
- DRF
- Device name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1220
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 185 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252794 | 2026-01-08 | Imricor Medical Systems, Inc. | Vision-MR Diagnostic Catheter | |
| K250590 | 2025-07-23 | Stereotaxis, Inc. | MAGiC Sweep EP Mapping Catheter | |
| K250310 | 2025-06-27 | Boston Scientific Corporation | VIKING Fixed Curve Diagnostic Catheter | |
| K240366 | 2024-11-01 | Boston Scientific Corporation | EPXT Unidirectional Steerable Diagnostic Catheter; | |
| K233900 | 2024-09-06 | Synaptic Medical Corporation | Nordica PV Cryo Mapping Catheter | |
| K233397 | 2023-12-02 | Medtronic, Inc. | Cosine-10TM Diagnostic Catheter | |
| K233207 | 2023-10-27 | Boston Scientific Corporation | Polaris X Unidirectional Steerable Diagnostic Cathe | |
| K232651 | 2023-09-29 | Boston Scientific Corporation | BLAZER Dx-20 Bidirectional Steerable Diagnostic Cat |
Official FDA classification page: DRF
Classification and pathway per current FDA publications. Data from openFDA (CC0).