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FDA 510(k)

Dimesol 一次性動靜脈造口針組(非安全系列)及Dimesol 一次性動靜脈造口針組(安全系列)

K 號:K171505 · 2018-05-17

申請人Dimesol, Inc.
決定日期2018-05-17
產品代碼FIE
諮詢委員會GU
決定相當於

器材摘要

Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) is the device name listed in this FDA 510(k) record. The listed applicant is Dimesol, Inc.. It received FDA 510(k) clearance on 2018-05-17 under 510(k) number K171505. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)?

Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) is a medical device that received FDA 510(k) clearance on 2018-05-17. The listed applicant is Dimesol, Inc.. The 510(k) number is K171505.

When did Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) receive FDA 510(k) clearance?

Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) received FDA 510(k) clearance on 2018-05-17, under 510(k) number K171505.

Who is the listed applicant for Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)?

The FDA 510(k) record lists Dimesol, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)?

The FDA product code for Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) is FIE.

相關臨床試驗

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其他以 Dimesol, Inc. 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。

相關器械(代碼:FIE)

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。

官方來源

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