FDA 510(k)

POT PTCA 擴張球囊心导管

K 號：K230705 · 2023-04-11

決定日期2023-04-11

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

POT PTCA 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 2023-04-11 under 510(k) number K230705. 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 POT PTCA Balloon Dilatation Catheter?

POT PTCA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-04-11. The listed applicant is Brosmed Medical Co., Ltd.. The 510(k) number is K230705.

When did POT PTCA Balloon Dilatation Catheter receive FDA 510(k) clearance?

POT PTCA Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-04-11, under 510(k) number K230705.

Who is the listed applicant for POT PTCA 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 POT PTCA Balloon Dilatation Catheter?

The FDA product code for POT PTCA Balloon Dilatation Catheter is LOX.

其他以 Brosmed Medical Co., Ltd. 為申請人之記錄

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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

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