CrossTorq 14 導絲
K 號：K193194 · 2019-12-13
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器材摘要
CrossTorq 14 Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Cardio Access, LLC. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K193194. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CrossTorq 14 Guidewire?
CrossTorq 14 Guidewire is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Scientia Cardio Access, LLC. The 510(k) number is K193194.
When did CrossTorq 14 Guidewire receive FDA 510(k) clearance?
CrossTorq 14 Guidewire received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193194.
Who is the listed applicant for CrossTorq 14 Guidewire?
The FDA 510(k) record lists Scientia Cardio Access, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CrossTorq 14 Guidewire?
The FDA product code for CrossTorq 14 Guidewire is DQX.
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相關器械（代碼：DQX）
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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