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FDA 510(k)

FreedomFlow Orbital Circumferential Atherectomy System

K-Number: K231538 · 2023-09-27

ApplicantCardio Flow Inc.,
Decision Date2023-09-27
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FreedomFlow Orbital Circumferential Atherectomy System is a medical device manufactured by Cardio Flow Inc.,. It received FDA 510(k) clearance on 2023-09-27 under approval number K231538. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FreedomFlow Orbital Circumferential Atherectomy System?

FreedomFlow Orbital Circumferential Atherectomy System is a medical device that received FDA 510(k) clearance on 2023-09-27. It is manufactured by Cardio Flow Inc.,. The 510(k) number is K231538.

When was FreedomFlow Orbital Circumferential Atherectomy System approved by the FDA?

FreedomFlow Orbital Circumferential Atherectomy System received FDA 510(k) clearance on 2023-09-27, under approval number K231538.

What company makes FreedomFlow Orbital Circumferential Atherectomy System?

FreedomFlow Orbital Circumferential Atherectomy System is manufactured by Cardio Flow Inc.,.

What is the FDA product code for FreedomFlow Orbital Circumferential Atherectomy System?

The FDA product code for FreedomFlow Orbital Circumferential Atherectomy System is MCW.

Related Clinical Trials

NCT04229563 Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease COMPLETED NCT06736899 Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions RECRUITING NCT06736665 Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK). RECRUITING NCT07360730 High-Purity Type I Collagen Nerve Wrapping in Peripheral Nerve Procedures: A Prospective Registry COMPLETED NCT07105930 Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach RECRUITING

Other Devices by Cardio Flow Inc.,

K213834Cardio Flow Peripheral Guide Wire K242947FreedomFlow™ Orbital Circumferential Atherectomy System K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)

Related Devices (Code: MCW)

K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledAvinger, Inc. K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. K160827Pantheris CatheterAvinger, Inc. K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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