FDA 510(k)

自動輸血（ATS）胸水吸引器：オーシャンウォーターセール胸水吸引器、オアシスドライ吸引胸水吸引器、エクスプレスドライシール胸水吸引器

K番号: K201305 · 2021-09-03

決定日2021-09-03

製品コードCAC

諮問委員会AN 当社の医療機器は、FDA（米国食品医薬品局）の規制に従って製造・販売されています。製品は、510(k)通知書およびPMA（プレマーケティング評価）を通じて承認を受けています。臨床試験情報は、NCT（臨床試験登録番号）およびPMID（PubMed ID）で確認できます。詳細情報や製品の詳細については、以下のURLをご参照ください。 [URL]

決定大幅同等

医療機器の概要

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corporation. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K201305. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain?

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Atrium Medical Corporation. The 510(k) number is K201305.

When did Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain receive FDA 510(k) clearance?

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain received FDA 510(k) clearance on 2021-09-03, under 510(k) number K201305.

Who is the listed applicant for Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain?

The FDA 510(k) record lists Atrium Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain?

The FDA product code for Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain is CAC.

申請者としてAtrium Medical Corporationを記載するその他の記録

K231972Advanta VXT Vascular Graft, Flixene Vascular Graft

公式ソース

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