FDA 510(k)

目標內頸動脈導管，目標週邊導管，目標腎導管

K 號：K172995 · 2017-11-21

決定日期2017-11-21

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal 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 2017-11-21 under 510(k) number K172995. 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 Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath?

Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Terumo Medical Corporation. The 510(k) number is K172995.

When did Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath receive FDA 510(k) clearance?

Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath received FDA 510(k) clearance on 2017-11-21, under 510(k) number K172995.

Who is the listed applicant for Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal 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 Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath?

The FDA product code for Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath 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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