FDA 510(k)

Tamarin藍PTCA RX 膨脹導管

K 號：K210012 · 2021-07-09

決定日期2021-07-09

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

Tamarin Blue PTCA RX Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Natec Medical , Ltd.. It received FDA 510(k) clearance on 2021-07-09 under 510(k) number K210012. 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 Tamarin Blue PTCA RX Dilatation Catheter?

Tamarin Blue PTCA RX Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-07-09. The listed applicant is Natec Medical , Ltd.. The 510(k) number is K210012.

When did Tamarin Blue PTCA RX Dilatation Catheter receive FDA 510(k) clearance?

Tamarin Blue PTCA RX Dilatation Catheter received FDA 510(k) clearance on 2021-07-09, under 510(k) number K210012.

Who is the listed applicant for Tamarin Blue PTCA RX Dilatation Catheter?

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

What is the FDA product code for Tamarin Blue PTCA RX Dilatation Catheter?

The FDA product code for Tamarin Blue PTCA RX Dilatation Catheter is LOX.

其他以 Natec 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。

K251915Amethyst HP PTA OTW 0.035 腔管 K241040Amethyst HP PTA OTW 0.035 腔管 K220410埃博尼HP PTA OTW 0.035 腹腔鏈管

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。