FDA 510(k)

Artimes pro 機械擴張導管

K 號：K203390 · 2021-04-14

決定日期2021-04-14

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

Artimes pro Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-04-14 under 510(k) number K203390. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Artimes pro Balloon Dilatation Catheter?

Artimes pro Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-04-14. The listed applicant is Brosmed Medical Co., Ltd.. The 510(k) number is K203390.

When did Artimes pro Balloon Dilatation Catheter receive FDA 510(k) clearance?

Artimes pro Balloon Dilatation Catheter received FDA 510(k) clearance on 2021-04-14, under 510(k) number K203390.

Who is the listed applicant for Artimes pro Balloon Dilatation Catheter?

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

What is the FDA product code for Artimes pro Balloon Dilatation Catheter?

The FDA product code for Artimes pro Balloon Dilatation Catheter is LOX.

其他以 Brosmed Medical Co., 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。

K243704Parafleet SC 014 PTA 擴張氣球導管；Parafleet SC 018 PTA 擴張氣球導管；Parafleet SC 035 PTA 擴張氣球導管 K241478三邊楔形PTA評分擴張針狀導管 K230705POT PTCA 擴張球囊心导管 K212215Tiche PTA 擴張球囊心导管 K160941卡斯多、阿基里斯和赫米斯NC PTA擴張球囊心导管 K153742Apollo 機械擴張導管

查看所有 8 項裝置 →

相關器械（代碼：LOX）

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。

K261428NC Euphora 快速交換氣球擴張導管Medtronic Ireland K261759Euphora Rapid Exchange (RX) 機械擴張導管Medtronic Ireland K252116消防員™ Pro PTCA 機械導管Shanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ 頸動脈-近端動脈成形術系統Verge Medical, Inc.K252295龍煉Terumo Corporation K251970Sprinter Legend 快速交換氣球擴張導管Medtronic, Ireland

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。