FDA 510(k)

導入鞘組合

K 號：K254248 · 2026-04-23

申請人Cardiocycle Medical(Suzhou) Co., Ltd.

決定日期2026-04-23

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

Introducer Sheath Set is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocycle Medical(Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-23 under 510(k) number K254248. 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 Introducer Sheath Set?

Introducer Sheath Set is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Cardiocycle Medical(Suzhou) Co., Ltd.. The 510(k) number is K254248.

When did Introducer Sheath Set receive FDA 510(k) clearance?

Introducer Sheath Set received FDA 510(k) clearance on 2026-04-23, under 510(k) number K254248.

Who is the listed applicant for Introducer Sheath Set?

The FDA 510(k) record lists Cardiocycle Medical(Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Introducer Sheath Set?

The FDA product code for Introducer Sheath Set is DYB.

其他以 Cardiocycle Medical(Suzhou) Co., Ltd. 為申請人之記錄

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K251838導入鞘組合

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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