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FDA PMA

分隔用於治療目的,膜自動血細胞/血漿

PMA 核准號:P820033 · 2026-04-09

決定日期2026-04-09
PMA 編號P820033
產品代碼MDP
器械分類3 類
醫療專科U
諮詢委員會GU

器材摘要

Separator for therapeutic purposes, membrane automated blood cell/plasma is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Kasei Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-04-09. The device is classified under product code MDP. It was reviewed by the GU advisory panel.

常見問題

What is the Separator for therapeutic purposes, membrane automated blood cell/plasma?

Separator for therapeutic purposes, membrane automated blood cell/plasma is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is Asahi Kasei Medical Co., Ltd..

When did Separator for therapeutic purposes, membrane automated blood cell/plasma receive FDA 510(k) clearance?

The clearance date for Separator for therapeutic purposes, membrane automated blood cell/plasma can be found in the official FDA records.

誰是治療用分離器的膜自動血細胞/血漿的登記申請人?

The FDA 510(k) record lists Asahi Kasei Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

FDA產品代碼為治療用分離器的膜自動血液細胞/膠質是什麼?

FDA產品代碼,用於治療目的的濾分器,膜自動血細胞/血漿為MDP。

相關臨床試驗

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官方來源

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