FDA 510(k)

ExsoMed アークフィックスおよびExsoMed アーローフィックス

K番号: K171407 · 2017-08-18

決定日2017-08-18

製品コードHWC

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

ExsoMed ArcPhix and ExsoMed ArrowPhix is the device name listed in this FDA 510(k) record. The listed applicant is Exsomed Holding Company, LLC. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K171407. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the ExsoMed ArcPhix and ExsoMed ArrowPhix?

ExsoMed ArcPhix and ExsoMed ArrowPhix is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Exsomed Holding Company, LLC. The 510(k) number is K171407.

When did ExsoMed ArcPhix and ExsoMed ArrowPhix receive FDA 510(k) clearance?

ExsoMed ArcPhix and ExsoMed ArrowPhix received FDA 510(k) clearance on 2017-08-18, under 510(k) number K171407.

Who is the listed applicant for ExsoMed ArcPhix and ExsoMed ArrowPhix?

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

What is the FDA product code for ExsoMed ArcPhix and ExsoMed ArrowPhix?

The FDA product code for ExsoMed ArcPhix and ExsoMed ArrowPhix is HWC. This falls under the Cardiovascular category.

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ExsoMed アークフィックスおよびExsoMed アーローフィックス

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：HWC）

公式ソース