FDA 510(k)

Lp(a) 超級

K 號：K211058 · 2022-12-22

決定日期2022-12-22

產品代碼DFC

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

Lp(a) Ultra is the device name listed in this FDA 510(k) record. The listed applicant is SENTINEL CH. SpA. It received FDA 510(k) clearance on 2022-12-22 under 510(k) number K211058. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lp(a) Ultra?

Lp(a) Ultra is a medical device that received FDA 510(k) clearance on 2022-12-22. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K211058.

When did Lp(a) Ultra receive FDA 510(k) clearance?

Lp(a) Ultra received FDA 510(k) clearance on 2022-12-22, under 510(k) number K211058.

Who is the listed applicant for Lp(a) Ultra?

The FDA 510(k) record lists SENTINEL CH. SpA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lp(a) Ultra?

The FDA product code for Lp(a) Ultra is DFC.

其他以 SENTINEL CH. SpA 為申請人之記錄

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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相關器械（代碼：DFC）

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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