愛德華eSheath+ 引導套組
K 號：K254279 · 2026-04-17
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器材摘要
Edwards eSheath+ introducer set is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K254279. 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 Edwards eSheath+ introducer set?
Edwards eSheath+ introducer set is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Edwards Lifesciences. The 510(k) number is K254279.
When did Edwards eSheath+ introducer set receive FDA 510(k) clearance?
Edwards eSheath+ introducer set received FDA 510(k) clearance on 2026-04-17, under 510(k) number K254279.
Who is the listed applicant for Edwards eSheath+ introducer set?
The FDA 510(k) record lists Edwards Lifesciences as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Edwards eSheath+ introducer set?
The FDA product code for Edwards eSheath+ introducer set is DYB.
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其他以 Edwards Lifesciences 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。
K254232ECLIPTIS 左心房顯影囊排除系統 (ECS135)；ECLIPTIS 左心房顯影囊排除系統 (ECS140)；ECLIPTIS 左心房顯影囊排除系統 (ECS145)；ECLIPTIS 左心房顯影囊排除系統 (ECS150)K260105Fogarty 強力夾釘，無把柄夾具，及夾具插片K252533HemoSphere Alta先進監控平台（ALTAALL1；ALTACR1；ALTASR1）K253034HemoSphere 流模組K252364愛德華eSheath Optima引導套件K243781HemoSphere 高級監視器 (HEM1)；HemoSphere 技術模組 (HEMTOM10)；HemoSphere 清晰視野模組 (HEMCSM10)；智能壓力控制器 (PC1Q)；Acumen IQ Plus 手腕帶 (AIQCA2)；HemoSphere 壓力纜 (HEMPSC100)；HemoSphere Vita 監視器 (HEMVITA1)；HemoSphere Vita 技術模組 (HEMVTOM1)；HemoSphere VitaWave 模組 (HEMVWM1)；VitaWave Plus 手腕帶 (VWCA2)
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
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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