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FDA 510(k)

SonoStik 引導絲引導器指南

K 號:K243061 · 2024-11-04

申請人Sonostik, LLC
決定日期2024-11-04
產品代碼DYB
諮詢委員會履歷
決定相當於

器材摘要

SonoStik Guide Wire Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Sonostik, LLC. It received FDA 510(k) clearance on 2024-11-04 under 510(k) number K243061. 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 SonoStik Guide Wire Introducer?

SonoStik Guide Wire Introducer is a medical device that received FDA 510(k) clearance on 2024-11-04. The listed applicant is Sonostik, LLC. The 510(k) number is K243061.

When did SonoStik Guide Wire Introducer receive FDA 510(k) clearance?

SonoStik Guide Wire Introducer received FDA 510(k) clearance on 2024-11-04, under 510(k) number K243061.

Who is the listed applicant for SonoStik Guide Wire Introducer?

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

What is the FDA product code for SonoStik Guide Wire Introducer?

The FDA product code for SonoStik Guide Wire Introducer is DYB.

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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。

官方來源

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