FDA 510(k)

zenith 遠端進入長鞘

K 號：K253359 · 2026-05-22

申請人Suzhou Zenith Vascular SciTech Limited

決定日期2026-05-22

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

Zenith Distal Access Long Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Zenith Vascular SciTech Limited. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K253359. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zenith Distal Access Long Sheath?

Zenith Distal Access Long Sheath is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Suzhou Zenith Vascular SciTech Limited. The 510(k) number is K253359.

When did Zenith Distal Access Long Sheath receive FDA 510(k) clearance?

Zenith Distal Access Long Sheath received FDA 510(k) clearance on 2026-05-22, under 510(k) number K253359.

Who is the listed applicant for Zenith Distal Access Long Sheath?

The FDA 510(k) record lists Suzhou Zenith Vascular SciTech Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zenith Distal Access Long Sheath?

The FDA product code for Zenith Distal Access Long Sheath is QJP.

其他以 Suzhou Zenith Vascular SciTech Limited 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：QJP）

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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