林精密導向式TS，導向式套管，擴張器
K 號：K202226 · 2020-12-15
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器材摘要
Lim Precision Steerable TS, Steerable Sheath, Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Heart, Ltd.. It received FDA 510(k) clearance on 2020-12-15 under 510(k) number K202226. 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 Lim Precision Steerable TS, Steerable Sheath, Dilator?
Lim Precision Steerable TS, Steerable Sheath, Dilator is a medical device that received FDA 510(k) clearance on 2020-12-15. The listed applicant is Keystone Heart, Ltd.. The 510(k) number is K202226.
When did Lim Precision Steerable TS, Steerable Sheath, Dilator receive FDA 510(k) clearance?
Lim Precision Steerable TS, Steerable Sheath, Dilator received FDA 510(k) clearance on 2020-12-15, under 510(k) number K202226.
Who is the listed applicant for Lim Precision Steerable TS, Steerable Sheath, Dilator?
The FDA 510(k) record lists Keystone Heart, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lim Precision Steerable TS, Steerable Sheath, Dilator?
The FDA product code for Lim Precision Steerable TS, Steerable Sheath, Dilator 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。
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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