FDA 510(k)

zenith 吸引針管；一次性吸引管路組

K 號：K252707 · 2026-05-20

申請人Suzhou Zenith Vascular SciTech Limited

決定日期2026-05-20

產品代碼NRY

諮詢委員會履歷

決定相當於

器材摘要

Zenith Aspiration Catheter; Disposable Aspiration Tubing Set 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 2026-05-20 under 510(k) number K252707. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zenith Aspiration Catheter; Disposable Aspiration Tubing Set?

Zenith Aspiration Catheter; Disposable Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is Suzhou Zenith Vascular SciTech Limited. The 510(k) number is K252707.

When did Zenith Aspiration Catheter; Disposable Aspiration Tubing Set receive FDA 510(k) clearance?

Zenith Aspiration Catheter; Disposable Aspiration Tubing Set received FDA 510(k) clearance on 2026-05-20, under 510(k) number K252707.

Who is the listed applicant for Zenith Aspiration Catheter; Disposable Aspiration Tubing Set?

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 Aspiration Catheter; Disposable Aspiration Tubing Set?

The FDA product code for Zenith Aspiration Catheter; Disposable Aspiration Tubing Set is NRY.

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。

K253359zenith 遠端進入長鞘 K252317zenith 微導絲 K243534微導管

相關器械（代碼：NRY）

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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