DiscCath針頭組
K 號:K212328 · 2021-09-26
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器材摘要
DiscCath Needle Set is the device name listed in this FDA 510(k) record. The listed applicant is Disccath, LLC. It received FDA 510(k) clearance on 2021-09-26 under 510(k) number K212328. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DiscCath Needle Set?
DiscCath Needle Set is a medical device that received FDA 510(k) clearance on 2021-09-26. The listed applicant is Disccath, LLC. The 510(k) number is K212328.
When did DiscCath Needle Set receive FDA 510(k) clearance?
DiscCath Needle Set received FDA 510(k) clearance on 2021-09-26, under 510(k) number K212328.
Who is the listed applicant for DiscCath Needle Set?
The FDA 510(k) record lists Disccath, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DiscCath Needle Set?
The FDA product code for DiscCath Needle Set is BSP.
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相關器械(代碼:BSP)
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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