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FDA 510(k)

EndoVive 一鍵式低輪廓初始置入PEG套件，配ENFit連接器，EndoVive 低輪廓一鍵式交換胃造口管套件，配ENFit連接器，EndoVive 一鍵式右角輸食組，配ENFit連接器，EndoVive 一鍵式壓力輸食組，配ENFit連接器，EndoVive 一鍵式减压管，配ENFit連接器

K 號：K161003 · 2016-06-17

申請人Boston Scientific Corporation
決定日期2016-06-17
產品代碼PIF
諮詢委員會GU
決定Unknown

器材摘要

EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-06-17 under 510(k) number K161003. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector?

EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Boston Scientific Corporation. The 510(k) number is K161003.

When did EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector receive FDA 510(k) clearance?

EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector received FDA 510(k) clearance on 2016-06-17, under 510(k) number K161003.

Who is the listed applicant for EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector?

The FDA product code for EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector is PIF.

相關臨床試驗

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其他以 Boston Scientific Corporation 為申請人之記錄

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相關器械（代碼：PIF）

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。

K260110danumed 食道造口按鈕擴充組Danumed Medizintechnik GmbHK253715Edi 尿管 ENFit 6Fr/48 cm (6893166)；Edi 尿管 ENFit 6Fr/49cm (6893273)；Edi 尿管 ENFit 6Fr/50cm (6893274)；Edi 尿管 ENFit 8Fr/50cm (6893275)；Edi 尿管 ENFit 8Fr/100cm (6893276)；Edi 尿管 ENFit 8Fr/125cm (6893277)；Edi 尿管 ENFit 12Fr/125cm (6893278)；Edi 尿管 ENFit 16Fr/125cm (6893279)Maquet Critical Care ABK254170經皮內視鏡胃造口術（PEG）套件Degania Silicone , Ltd.K242917腸內引流系統，腸內藥劑吸管HMC Premedical S.p.A.K250481延伸喂食設備搭配ENFit™連接器SKY Medical, a.s.K240052一次性腸內營養輸注套組Beijing L&Z Medical Technology Development Co., Ltd.

官方來源

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