FDA 510(k)

EXTesia 引導鞘組合

K 號：K220604 · 2022-04-27

決定日期2022-04-27

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

EXTesia Introducer Sheath Set is the device name listed in this FDA 510(k) record. The listed applicant is Curatia Medical Co.. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K220604. 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 EXTesia Introducer Sheath Set?

EXTesia Introducer Sheath Set is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Curatia Medical Co.. The 510(k) number is K220604.

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

EXTesia Introducer Sheath Set received FDA 510(k) clearance on 2022-04-27, under 510(k) number K220604.

Who is the listed applicant for EXTesia Introducer Sheath Set?

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

What is the FDA product code for EXTesia Introducer Sheath Set?

The FDA product code for EXTesia Introducer Sheath Set is DYB.

其他以 Curatia Medical Co. 為申請人之記錄

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K180797Xcess 引導導管

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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