FDA 510(k)

臓器灌流用カニューラ

K番号: K203262 · 2021-07-01

決定日2021-07-01

製品コードKDN

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

Cannula for Organ Perfusion is the device name listed in this FDA 510(k) record. The listed applicant is Bridge TO Life, Ltd.. It received FDA 510(k) clearance on 2021-07-01 under 510(k) number K203262. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Cannula for Organ Perfusion?

Cannula for Organ Perfusion is a medical device that received FDA 510(k) clearance on 2021-07-01. The listed applicant is Bridge TO Life, Ltd.. The 510(k) number is K203262.

When did Cannula for Organ Perfusion receive FDA 510(k) clearance?

Cannula for Organ Perfusion received FDA 510(k) clearance on 2021-07-01, under 510(k) number K203262.

Who is the listed applicant for Cannula for Organ Perfusion?

The FDA 510(k) record lists Bridge TO Life, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cannula for Organ Perfusion?

The FDA product code for Cannula for Organ Perfusion is KDN.

申請者としてBridge TO Life, Ltd.を記載するその他の記録

K241239オーガンプロテックスHTKソリューション K191006EasiSlush

公式ソース

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