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FDA 510(k)

Sentrant 引導鞘，具有親水塗層

K 號：K171866 · 2017-12-20

申請人Medtronic Vascular, Inc.
決定日期2017-12-20
產品代碼DYB
諮詢委員會履歷
決定相當於

器材摘要

Sentrant Introducer Sheath with Hydrophilic Coating is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2017-12-20 under 510(k) number K171866. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sentrant Introducer Sheath with Hydrophilic Coating?

Sentrant Introducer Sheath with Hydrophilic Coating is a medical device that received FDA 510(k) clearance on 2017-12-20. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K171866.

When did Sentrant Introducer Sheath with Hydrophilic Coating receive FDA 510(k) clearance?

Sentrant Introducer Sheath with Hydrophilic Coating received FDA 510(k) clearance on 2017-12-20, under 510(k) number K171866.

Who is the listed applicant for Sentrant Introducer Sheath with Hydrophilic Coating?

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

What is the FDA product code for Sentrant Introducer Sheath with Hydrophilic Coating?

The FDA product code for Sentrant Introducer Sheath with Hydrophilic Coating is DYB.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Medtronic Vascular, 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。

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相關器械（代碼：DYB）

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。

K253526NAMIC 扩張器及套管Medline Industries, LPK261529微穿刺套件 / 微穿刺接入套件 / 微穿刺導入器組 / 微導入器套件 / 微導入器套件（SIS05C）；微穿刺套件 / 微穿刺接入套件 / 微穿刺導入器組 / 微導入器套件 / 微導入器套件（IS01）；導入器套件 / 微導入器套件 / 導入器組 / 微導入器組 / 微導入器鞘組 / 導入器鞘組（NIS04）Hartman Medical Group, LLCK261242簡易導引PendracareK261950健康線拆離導入器Health Line International CorporationK261492FieldFlex 經導鞘CenterPoint Systems, LLCK260606回聲大內徑導入鞘Echo Medical, LLC

官方來源

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