MCW — Catheter, Peripheral, Atherectomy Class II
FDA product code MCW covers "Catheter, Peripheral, Atherectomy", a Class II medical device regulated under 21 CFR 870.4875. 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
- MCW
- Device Class
- Class II
- Regulation Number
- 870.4875
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260244 | Eximo Medical | Auryon Atherectomy System | Apr 10, 2026 |
| K250723 | Cardio Flow Inc | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Con | Apr 25, 2025 |
| K250385 | Spectranetics | Turbo-Elite Laser Atherectomy Catheter | Mar 13, 2025 |
| K242757 | Bard Peripheral Vascular | Rotarex Atherectomy System | Jan 30, 2025 |
| K242947 | Cardio Flow Inc | FreedomFlow Orbital Circumferential Atherectomy System | Nov 5, 2024 |
| K241553 | Eximo Medical | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophili | Jun 27, 2024 |
| K233483 | Cardio Flow Inc | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Confi | Feb 15, 2024 |
| K233668 | Eximo Medical | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Aury | Dec 15, 2023 |
| K231538 | Cardio Flow Inc | FreedomFlow Orbital Circumferential Atherectomy System | Sep 27, 2023 |
| K230709 | Eximo Medical | Auryon Atherectomy System | Jun 9, 2023 |
| K230005 | Avinger | Pantheris LV Atherectomy Catheter | Jun 6, 2023 |
| K222837 | Spectranetics | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Ather | Dec 8, 2022 |
| K220116 | Eximo Medical | Auryon Atherectomy Catheters | Sep 26, 2022 |
| K220962 | Boston Scientific Corporation | ROTAPRO Rotational Atherectomy System | Sep 6, 2022 |
| K221077 | Eximo Medical | Auryon Atherectomy System | Jun 9, 2022 |
| K220568 | Cardiovascualr Systems | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Or | Apr 27, 2022 |
| K220109 | Cardiovascular Systems | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Periphera | Mar 1, 2022 |
| K212351 | Rex Medical, L.P | Revolution Peripheral Atherectomy System | Dec 15, 2021 |
| K212047 | Avinger | Pantheris System | Nov 16, 2021 |
| K211738 | C.R. Bard | Rotarex Atherectomy System | Sep 14, 2021 |