FDA 510(k)

超級套管

K 號：K200379 · 2020-03-19

決定日期2020-03-19

產品代碼DRE

諮詢委員會履歷

決定相當於

器材摘要

Super Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Togo Medikit Co., Ltd.. It received FDA 510(k) clearance on 2020-03-19 under 510(k) number K200379. 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 Super Sheath?

Super Sheath is a medical device that received FDA 510(k) clearance on 2020-03-19. The listed applicant is Togo Medikit Co., Ltd.. The 510(k) number is K200379.

When did Super Sheath receive FDA 510(k) clearance?

Super Sheath received FDA 510(k) clearance on 2020-03-19, under 510(k) number K200379.

Who is the listed applicant for Super Sheath?

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

What is the FDA product code for Super Sheath?

The FDA product code for Super Sheath is DRE.

其他以 Togo Medikit Co., Ltd. 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。

K241230超級套管導入套管 S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 K190001超心貫 5 K172496超心導管 5 (26G)K160592超心導管 6

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。

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官方來源

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