FDA 510(k)

FreedomFlow 軌道環形動脈內切除系統（H6004/5Fr 3-球體配置）

K 號：K233483 · 2024-02-15

決定日期2024-02-15

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 (H6004/5Fr 3-Sphere Configuration) 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 2024-02-15 under 510(k) number K233483. 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 (H6004/5Fr 3-Sphere Configuration)?

FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Cardio Flow Inc.,. The 510(k) number is K233483.

When did FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) receive FDA 510(k) clearance?

FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) received FDA 510(k) clearance on 2024-02-15, under 510(k) number K233483.

Who is the listed applicant for FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)?

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 (H6004/5Fr 3-Sphere Configuration)?

The FDA product code for FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) 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)K242947FreedomFlow™ 軌道環形動脈內切除系統 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.K242947FreedomFlow™ 軌道環形動脈內切除系統Cardio Flow Inc.,K241553Auryon 腺切除导管 1.7mm; Auryon 腺切除导管 1.7mm, 水性塗層Eximo Medical, Ltd.

官方來源

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