MTD
- Product code
- MTD
- Device name
- Catheter, Intracardiac Mapping, High-Density Array
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1220
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 34 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261012 | 2026-04-23 | Cortex, Inc. | OptiMap Catheter - 60mm (OPTI-CATH2-60) | |
| K253205 | 2026-03-13 | Cortex, Inc. | OptiMap Catheter - 50mm (OPTI-CATH2-50) | |
| K233433 | 2024-08-07 | Medtronic | Sphere-9Dx Diagnostic Catheter (AFR-00009) | |
| K241372 | 2024-07-09 | ABBOTT MEDICAL | Advisor HD Grid X Mapping Catheter, Sensor Enabled |
Official FDA classification page: MTD
Classification and pathway per current FDA publications. Data from openFDA (CC0).