FDA 510(k)

TR BAND 径向壓縮設備

K 號：K213531 · 2021-12-20

決定日期2021-12-20

產品代碼DXC

諮詢委員會履歷

決定相當於

器材摘要

TR BAND Radial Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corporation. It received FDA 510(k) clearance on 2021-12-20 under 510(k) number K213531. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TR BAND Radial Compression Device?

TR BAND Radial Compression Device is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is Terumo Medical Corporation. The 510(k) number is K213531.

When did TR BAND Radial Compression Device receive FDA 510(k) clearance?

TR BAND Radial Compression Device received FDA 510(k) clearance on 2021-12-20, under 510(k) number K213531.

Who is the listed applicant for TR BAND Radial Compression Device?

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

What is the FDA product code for TR BAND Radial Compression Device?

The FDA product code for TR BAND Radial Compression Device is DXC.

其他以 Terumo Medical Corporation 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。

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相關器械（代碼：DXC）

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。

K262086PreludeSYNC™ 徑向壓縮設備Merit Medical Systems, Inc.K260105Fogarty 強力夾釘，無把柄夾具，及夾具插片Edwards Lifesciences K252772Arc 可調節放射狀袖口壓縮設備Tz Medical, Inc.K254060救命止血帶TW Medical K243627喉鏡節段性動脈限制夾 (L-ARC)；動脈限制夾 (ARC)Arc Trauma, LLC K253070Namic 放射臂帶，23 公分（DYNJRADBAND）；Namic 放射臂帶，26 公分（DYNJRADBANDL）Medline Industries, LP

官方來源

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