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FDA 510(k)

ExpanSure 大型經隔膜擴張器

K 號：K201288 · 2020-06-12

申請人Baylis Medical Company, Inc.
決定日期2020-06-12
產品代碼DRE
諮詢委員會履歷
決定相當於

器材摘要

ExpanSure Large Access Transseptal Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2020-06-12 under 510(k) number K201288. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ExpanSure Large Access Transseptal Dilator?

ExpanSure Large Access Transseptal Dilator is a medical device that received FDA 510(k) clearance on 2020-06-12. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K201288.

When did ExpanSure Large Access Transseptal Dilator receive FDA 510(k) clearance?

ExpanSure Large Access Transseptal Dilator received FDA 510(k) clearance on 2020-06-12, under 510(k) number K201288.

Who is the listed applicant for ExpanSure Large Access Transseptal Dilator?

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

What is the FDA product code for ExpanSure Large Access Transseptal Dilator?

The FDA product code for ExpanSure Large Access Transseptal Dilator is DRE.

相關臨床試驗

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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其他以 Baylis Medical Company, Inc. 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：DRE）

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。

K261310FlexTract 可調向旋轉擴張針鞘組Merit Medical Systems, Inc.K253616ProtekDilate 血管通路套件Sorin Group Italia S.R.L.K251325VersaCross Connect™ 開窗擴張器Baylis Medical Company, Inc.K242229微針金進階微針接入系統Merit Medical Systems, Inc.K241720VersaCross Connect™ 開窗擴張器Baylis Medical Company, Inc.K233647VersaCross Connect™ 開窗擴張器Baylis Medical Company, Inc.

官方來源

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