FDA 510(k)

多向導向外鞘 17.5F

K 號：K260626 · 2026-03-26

決定日期2026-03-26

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

Multiflex Steerable Sheath 17.5F is the device name listed in this FDA 510(k) record. The listed applicant is Vizaramed, Inc.. It received FDA 510(k) clearance on 2026-03-26 under 510(k) number K260626. 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 Multiflex Steerable Sheath 17.5F?

Multiflex Steerable Sheath 17.5F is a medical device that received FDA 510(k) clearance on 2026-03-26. The listed applicant is Vizaramed, Inc.. The 510(k) number is K260626.

When did Multiflex Steerable Sheath 17.5F receive FDA 510(k) clearance?

Multiflex Steerable Sheath 17.5F received FDA 510(k) clearance on 2026-03-26, under 510(k) number K260626.

Who is the listed applicant for Multiflex Steerable Sheath 17.5F?

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

What is the FDA product code for Multiflex Steerable Sheath 17.5F?

The FDA product code for Multiflex Steerable Sheath 17.5F is DYB.

其他以 Vizaramed, Inc. 為申請人之記錄

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K221655多向導向式套管

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。

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官方來源

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