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FDA 510(k)

Selectra Catheters, Selectra Accessory Kit

K 號：K183265 · 2018-12-13

申請人Biotronik, Inc.
決定日期2018-12-13
產品代碼DQY
諮詢委員會CV
決定Substantially Equivalent

器材摘要

Selectra Catheters, Selectra Accessory Kit is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K183265. 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 Selectra Catheters, Selectra Accessory Kit?

Selectra Catheters, Selectra Accessory Kit is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Biotronik, Inc.. The 510(k) number is K183265.

When did Selectra Catheters, Selectra Accessory Kit receive FDA 510(k) clearance?

Selectra Catheters, Selectra Accessory Kit received FDA 510(k) clearance on 2018-12-13, under 510(k) number K183265.

Who is the listed applicant for Selectra Catheters, Selectra Accessory Kit?

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

What is the FDA product code for Selectra Catheters, Selectra Accessory Kit?

The FDA product code for Selectra Catheters, Selectra Accessory Kit is DQY.

相關臨床試驗

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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其他以 Biotronik, 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。

K261074BIOMONITOR IV (471155)K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterK242969Pantera Pro; Pantera LEOK240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)K241711Oscar Peripheral Multifunctional Catheter systemK230375BIOMONITOR IV

查看所有 23 項裝置 →

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 Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT 輸送導管CenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管Abbott

官方來源

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