Atherectomy
FreedomFlow Orbital Circumferential Atherectomy System
A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.
FreedomFlow Orbital Circumferential Atherectomy System models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| H6001 | Atherectomy Rotating Component Diameter 1.5 mm | Not stated | Available |
| H6002 | Atherectomy Rotating Component Diameter 2.0 mm | Not stated | Available |
| H6004 | Atherectomy Rotating Component Diameter 1.5 mm | Not stated | Available |
FDA clearances
- 510(k) K231538 September 2023
Procedures that use atherectomy
Frequently asked questions
What is FreedomFlow Orbital Circumferential Atherectomy System used for?
A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.
Who makes FreedomFlow Orbital Circumferential Atherectomy System?
FreedomFlow Orbital Circumferential Atherectomy System is made by Cardio Flow, Inc.. It is listed under atherectomy devices in our device library.
What sizes does FreedomFlow Orbital Circumferential Atherectomy System come in?
Sizes listed for FreedomFlow Orbital Circumferential Atherectomy System: Atherectomy Rotating Component Diameter: 1.5–2 mm. Confirm availability with the manufacturer's instructions for use.
Is FreedomFlow Orbital Circumferential Atherectomy System MRI safe?
The FDA device database entry for FreedomFlow Orbital Circumferential Atherectomy System does not state its MRI safety status. Check the labeling before MRI.
Is FreedomFlow Orbital Circumferential Atherectomy System FDA cleared?
FreedomFlow Orbital Circumferential Atherectomy System is covered by FDA submission K231538.
How do I contact a Cardio Flow, Inc. sales representative?
Cardio Flow, Inc. has not listed representatives on LA Vascular yet. Visit the Cardio Flow, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.