MCW · Catheter, Peripheral, Atherectomy
Cardiovascular · 21 CFR 870.4875 · Class 2
Overview
| Product Code | MCW |
|---|---|
| Device Name | Catheter, Peripheral, Atherectomy |
| Regulation | 21 CFR 870.4875 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 146)
Showing 20 most recent of 146 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260244 | Auryon Atherectomy System | Eximo Medical | Apr 10, 2026 | SESE |
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | Cardio Flow Inc., | Apr 25, 2025 | SESE |
| K250385 | Turbo-Elite Laser Atherectomy Catheter | Spectranetics | Mar 13, 2025 | SESE |
| K242757 | Rotarex Atherectomy System | Bard Peripheral Vascular, Inc. | Jan 30, 2025 | SESE |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., | Nov 5, 2024 | SESE |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | Eximo Medical, Ltd. | Jun 27, 2024 | SESE |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) | Cardio Flow Inc., | Feb 15, 2024 | SESE |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) | Eximo Medical, Ltd. | Dec 15, 2023 | SESE |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., | Sep 27, 2023 | SESE |
| K230709 | Auryon Atherectomy System | Eximo Medical, Ltd. | Jun 9, 2023 | SESE |
| K230005 | Pantheris LV Atherectomy Catheter | Avinger, Inc. | Jun 6, 2023 | SESE |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Spectranetics, Inc. | Dec 8, 2022 | SESE |
| K220116 | Auryon Atherectomy Catheters | Eximo Medical, Ltd. | Sep 26, 2022 | SESE |
| K220962 | ROTAPRO Rotational Atherectomy System | Boston Scientific Corporation | Sep 6, 2022 | SESE |
| K221077 | Auryon Atherectomy System | Eximo Medical, Ltd. | Jun 9, 2022 | SESE |
| K220568 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | Cardiovascualr Systems, Inc. | Apr 27, 2022 | SESE |
| K220109 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems, Inc. | Mar 1, 2022 | SESE |
| K212351 | Revolution Peripheral Atherectomy System | Rex Medical, L.P. | Dec 15, 2021 | SESE |
| K212047 | Pantheris System | Avinger, Inc. | Nov 16, 2021 | SESE |
| K211738 | Rotarex Atherectomy System | C.R. Bard, Inc. | Sep 14, 2021 | SESE |
Top Applicants
- Cardiovascular Systems, Inc. — 19 clearances
- Pathway Medical Technologies, Inc. — 16 clearances
- Avinger, Inc. — 10 clearances
- Eximo Medical, Ltd. — 7 clearances
- Spectranetics, Inc. — 6 clearances
