FDA 510(k)

Auryon 開心術系統

K 號：K230709 · 2023-06-09

決定日期2023-06-09

產品代碼MCW

諮詢委員會履歷

決定相當於

器材摘要

Auryon Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Eximo Medical, Ltd.. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K230709. 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 Auryon Atherectomy System?

Auryon Atherectomy System is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Eximo Medical, Ltd.. The 510(k) number is K230709.

When did Auryon Atherectomy System receive FDA 510(k) clearance?

Auryon Atherectomy System received FDA 510(k) clearance on 2023-06-09, under 510(k) number K230709.

Who is the listed applicant for Auryon Atherectomy System?

The FDA 510(k) record lists Eximo Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auryon Atherectomy System?

The FDA product code for Auryon Atherectomy System is MCW.

其他以 Eximo Medical, Ltd. 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。

K241553Auryon 腺切除导管 1.7mm; Auryon 腺切除导管 1.7mm, 水性塗層 K233668Auryon 腺切除导管 1.5 mm XL, 水性塗層 (EXM-4010-H000), Auryon 腺切除导管 0.9 mm XL, 水性塗層 (EXM-4011-H000), Auryon 腺切除导管 1.5 mm XL (EXM -4010-0000), Auryon 腺切除导管 0.9 mm XL (EXM-4011-0000)K220116Auryon 腺切除导管 K221077Auryon 開心術系統 K202835Auryon 開心術系統 K181642B-Laser動脈內切除系統

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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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