FreedomFlow Orbital Circumferential Atherectomy System
FDA 510(k) K231538 · Cardio Flow Inc.,
510(k) numberK231538
Submission
- Device name
- FreedomFlow Orbital Circumferential Atherectomy System
- Applicant
- Cardio Flow Inc.,
Blaine, MN, US - Received
- May 30, 2023
- Decision date
- September 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
Other 510(k)s with product code MCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260244 | Auryon Atherectomy SystemMCW · Traditional | Eximo Medical | 04/10/2026SE |
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…MCW · Special | Cardio Flow Inc., | 04/25/2025SE |
| K250385 | Turbo-Elite Laser Atherectomy CatheterMCW · Special | Spectranetics | 03/13/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | Bard Peripheral Vascular, Inc. | 01/30/2025SE |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Special | Cardio Flow Inc., | 11/05/2024SE |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingMCW · Special | Eximo Medical, Ltd. | 06/27/2024SE |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)MCW · Special | Cardio Flow Inc., | 02/15/2024SE |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…MCW · Special | Eximo Medical, Ltd. | 12/15/2023SE |
| K230709 | Auryon Atherectomy SystemMCW · Special | Eximo Medical, Ltd. | 06/09/2023SE |
| K230005 | Pantheris LV Atherectomy CatheterMCW · Traditional | Avinger, Inc. | 06/06/2023SE |
More from Avinger, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…MCW · Special | 04/25/2025SE |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Special | 11/05/2024SE |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)MCW · Special | 02/15/2024SE |
| K213834 | Cardio Flow Peripheral Guide WireDQX · Traditional | 03/18/2022SE |
Questions and answers
When was FreedomFlow Orbital Circumferential Atherectomy System cleared by the FDA?
FreedomFlow Orbital Circumferential Atherectomy System (K231538) received a 510(k) decision of Substantially Equivalent on September 27, 2023, 120 days after the submission was received.
What is the product code of K231538?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.