FDA 510(k)

R2P 目標細導引外鞘

K 號：K171491 · 2017-10-05

決定日期2017-10-05

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

R2P Destination Slender Guiding Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corporation. It received FDA 510(k) clearance on 2017-10-05 under 510(k) number K171491. 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 R2P Destination Slender Guiding Sheath?

R2P Destination Slender Guiding Sheath is a medical device that received FDA 510(k) clearance on 2017-10-05. The listed applicant is Terumo Medical Corporation. The 510(k) number is K171491.

When did R2P Destination Slender Guiding Sheath receive FDA 510(k) clearance?

R2P Destination Slender Guiding Sheath received FDA 510(k) clearance on 2017-10-05, under 510(k) number K171491.

Who is the listed applicant for R2P Destination Slender Guiding Sheath?

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

What is the FDA product code for R2P Destination Slender Guiding Sheath?

The FDA product code for R2P Destination Slender Guiding Sheath is DYB.

其他以 Terumo Medical Corporation 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：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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