FDA 510(k)

滑鞘細長胫骨足板套件

K 號：K181237 · 2018-08-03

決定日期2018-08-03

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

Glidesheath Slender Tibial Pedal Kit 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 2018-08-03 under 510(k) number K181237. 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 Glidesheath Slender Tibial Pedal Kit?

Glidesheath Slender Tibial Pedal Kit is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is Terumo Medical Corporation. The 510(k) number is K181237.

When did Glidesheath Slender Tibial Pedal Kit receive FDA 510(k) clearance?

Glidesheath Slender Tibial Pedal Kit received FDA 510(k) clearance on 2018-08-03, under 510(k) number K181237.

Who is the listed applicant for Glidesheath Slender Tibial Pedal Kit?

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 Glidesheath Slender Tibial Pedal Kit?

The FDA product code for Glidesheath Slender Tibial Pedal Kit is DYB.

其他以 Terumo Medical Corporation 為申請人之記錄

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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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