FDA 510(k)

FreedomFlow™ 軌道環形動脈內切除系統

K 號：K242947 · 2024-11-05

決定日期2024-11-05

產品代碼MCW

諮詢委員會履歷

決定相當於

器材摘要

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 2024-11-05 under 510(k) number K242947. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FreedomFlow™ Orbital Circumferential Atherectomy System?

FreedomFlow™ Orbital Circumferential Atherectomy System is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Cardio Flow Inc.,. The 510(k) number is K242947.

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

FreedomFlow™ Orbital Circumferential Atherectomy System received FDA 510(k) clearance on 2024-11-05, under 510(k) number K242947.

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.

其他以 Cardio Flow Inc., 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250723FreedomFlow™ 軌道環形動脈內脫落術系統 (H6005/ 4Fr 3-球體配置)K233483FreedomFlow 軌道環形動脈內切除系統（H6004/5Fr 3-球體配置）K231538FreedomFlow 軌道環形動脈內切除系統 K213834心臟血流周邊導引絲

相關器械（代碼：MCW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260244Auryon 開心術系統Eximo Medical K250723FreedomFlow™ 軌道環形動脈內脫落術系統 (H6005/ 4Fr 3-球體配置)Cardio Flow Inc.,K250385超級精英雷射動脈內切除針Spectranetics K242757Rotarex 銳術系統Bard Peripheral Vascular, Inc.K241553Auryon 腺切除导管 1.7mm; Auryon 腺切除导管 1.7mm, 水性塗層Eximo Medical, Ltd.K233483FreedomFlow 軌道環形動脈內切除系統（H6004/5Fr 3-球體配置）Cardio Flow Inc.,

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