FDA 510(k)

XableCath 支援導管

K 號：K170041 · 2017-09-07

決定日期2017-09-07

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

XableCath Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Xablecath, Inc.. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K170041. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XableCath Support Catheter?

XableCath Support Catheter is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Xablecath, Inc.. The 510(k) number is K170041.

When did XableCath Support Catheter receive FDA 510(k) clearance?

XableCath Support Catheter received FDA 510(k) clearance on 2017-09-07, under 510(k) number K170041.

Who is the listed applicant for XableCath Support Catheter?

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

What is the FDA product code for XableCath Support Catheter?

The FDA product code for XableCath Support Catheter is DQY.

其他以 Xablecath, Inc. 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。

K183357XableCath 穿刺導管 K180986XableCath 支援導管產品系列

相關器械（代碼：DQY）

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。

K262817CrossFAST整合式微导管先進輸送系統Vantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift 管針Alembic, LLC K262240SSPC NXT 輸送導管CenterPoint Systems, LLC K261766CPS 定位器 3D Plus 輸送导管CenterPoint Systems, LLC K261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管Abbott

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。