心曲導管
K 號：K210185 · 2021-07-23
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器材摘要
CardioCurve Steerable Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Talon Surgical. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K210185. 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 CardioCurve Steerable Sheath?
CardioCurve Steerable Sheath is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Talon Surgical. The 510(k) number is K210185.
When did CardioCurve Steerable Sheath receive FDA 510(k) clearance?
CardioCurve Steerable Sheath received FDA 510(k) clearance on 2021-07-23, under 510(k) number K210185.
Who is the listed applicant for CardioCurve Steerable Sheath?
The FDA 510(k) record lists Talon Surgical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CardioCurve Steerable Sheath?
The FDA product code for CardioCurve Steerable 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。
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官方來源
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