VANES 針對系統 (VDS)
K 號：K260459 · 2026-04-06
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器材摘要
VANES Delivery System (VDS) is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Respicardia, Inc.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K260459. 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 VANES Delivery System (VDS)?
VANES Delivery System (VDS) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Zoll Respicardia, Inc.. The 510(k) number is K260459.
When did VANES Delivery System (VDS) receive FDA 510(k) clearance?
VANES Delivery System (VDS) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K260459.
Who is the listed applicant for VANES Delivery System (VDS)?
The FDA 510(k) record lists Zoll Respicardia, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VANES Delivery System (VDS)?
The FDA product code for VANES Delivery System (VDS) 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。
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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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