FDA 510(k)

終端內膜壓力感知鞘套組-8F

K 號：K173399 · 2017-11-30

決定日期2017-11-30

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

Endophys Pressure Sensing Sheath Kit- 8F is the device name listed in this FDA 510(k) record. The listed applicant is Endophys Holdings, LLC. It received FDA 510(k) clearance on 2017-11-30 under 510(k) number K173399. 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 Endophys Pressure Sensing Sheath Kit- 8F?

Endophys Pressure Sensing Sheath Kit- 8F is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is Endophys Holdings, LLC. The 510(k) number is K173399.

When did Endophys Pressure Sensing Sheath Kit- 8F receive FDA 510(k) clearance?

Endophys Pressure Sensing Sheath Kit- 8F received FDA 510(k) clearance on 2017-11-30, under 510(k) number K173399.

Who is the listed applicant for Endophys Pressure Sensing Sheath Kit- 8F?

The FDA 510(k) record lists Endophys Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endophys Pressure Sensing Sheath Kit- 8F?

The FDA product code for Endophys Pressure Sensing Sheath Kit- 8F is DYB.

其他以 Endophys Holdings, LLC 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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官方來源

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