回聲大內徑導入鞘
K 號：K260606 · 2026-04-29
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器材摘要
Echo Large Bore Introducer Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Echo Medical, LLC. It received FDA 510(k) clearance on 2026-04-29 under 510(k) number K260606. 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 Echo Large Bore Introducer Sheath?
Echo Large Bore Introducer Sheath is a medical device that received FDA 510(k) clearance on 2026-04-29. The listed applicant is Echo Medical, LLC. The 510(k) number is K260606.
When did Echo Large Bore Introducer Sheath receive FDA 510(k) clearance?
Echo Large Bore Introducer Sheath received FDA 510(k) clearance on 2026-04-29, under 510(k) number K260606.
Who is the listed applicant for Echo Large Bore Introducer Sheath?
The FDA 510(k) record lists Echo Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Echo Large Bore Introducer Sheath?
The FDA product code for Echo Large Bore Introducer Sheath is DYB.
相關臨床試驗
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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, LLCK254248導入鞘組合Cardiocycle Medical(Suzhou) Co., Ltd.
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。
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