MCW — Catheter, Peripheral, Atherectomy Class II
FDA Device Classification
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 |
|---|
| K250723 | cardio flow inc | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Con | April 25, 2025 |
| K250385 | spectranetics | Turbo-Elite Laser Atherectomy Catheter | March 13, 2025 |
| K242757 | bard peripheral vascular | Rotarex Atherectomy System | January 30, 2025 |
| K242947 | cardio flow inc | FreedomFlow Orbital Circumferential Atherectomy System | November 5, 2024 |
| K241553 | eximo medical | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophili | June 27, 2024 |
| K233483 | cardio flow inc | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Confi | February 15, 2024 |
| K233668 | eximo medical | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Aury | December 15, 2023 |
| K231538 | cardio flow inc | FreedomFlow Orbital Circumferential Atherectomy System | September 27, 2023 |
| K230709 | eximo medical | Auryon Atherectomy System | June 9, 2023 |
| K230005 | avinger | Pantheris LV Atherectomy Catheter | June 6, 2023 |
| K222837 | spectranetics | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Ather | December 8, 2022 |
| K220116 | eximo medical | Auryon Atherectomy Catheters | September 26, 2022 |
| K220962 | boston scientific corporation | ROTAPRO Rotational Atherectomy System | September 6, 2022 |
| K221077 | eximo medical | Auryon Atherectomy System | June 9, 2022 |
| K220568 | cardiovascualr systems | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Or | April 27, 2022 |
| K220109 | cardiovascular systems | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Periphera | March 1, 2022 |
| K212351 | rex medical, l.p | Revolution Peripheral Atherectomy System | December 15, 2021 |
| K212047 | avinger | Pantheris System | November 16, 2021 |
| K210586 | cardiovascular systems | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Or | September 14, 2021 |
| K211738 | c.r. bard | Rotarex Atherectomy System | September 14, 2021 |