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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 the device name listed in this FDA 510(k) record. The listed applicant is Cardio Flow Inc.,. It received FDA 510(k) clearance on 2023-09-27 under 510(k) 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. The listed applicant is Cardio Flow Inc.,. The 510(k) number is K231538.

When did FreedomFlow Orbital Circumferential Atherectomy System receive FDA 510(k) clearance?

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

Who is the listed applicant for FreedomFlow Orbital Circumferential Atherectomy System?

The FDA 510(k) record lists Cardio Flow Inc., as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Cardio Flow Inc., as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemK233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)K213834Cardio Flow Peripheral Guide Wire

Related Devices (Code: MCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260244Auryon Atherectomy SystemEximo MedicalK250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectraneticsK242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

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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