MCW
- Product code
- MCW
- Device name
- Catheter, Peripheral, Atherectomy
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4875
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 9
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 146 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260244 | 2026-04-10 | Eximo Medical | Auryon Atherectomy System | |
| K250723 | 2025-04-25 | Cardio Flow Inc., | FreedomFlow Orbital Circumferential Atherectomy Sys | |
| K250385 | 2025-03-13 | Spectranetics | Turbo-Elite Laser Atherectomy Catheter | |
| K242757 | 2025-01-30 | Bard Peripheral Vascular, Inc. | Rotarex Atherectomy System | |
| K242947 | 2024-11-05 | Cardio Flow Inc., | FreedomFlow Orbital Circumferential Atherectomy Sys | |
| K241553 | 2024-06-27 | Eximo Medical, Ltd. | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectom | |
| K233483 | 2024-02-15 | Cardio Flow Inc., | FreedomFlow Orbital Circumferential Atherectomy Syst | FDA |
| K233668 | 2023-12-15 | Eximo Medical, Ltd. | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic C | |
| K231538 | 2023-09-27 | Cardio Flow Inc., | FreedomFlow Orbital Circumferential Atherectomy Syst |
Official FDA classification page: MCW
Classification and pathway per current FDA publications. Data from openFDA (CC0).