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FDA 510(k)

一次性高壓延伸線

K 號：K230668 · 2024-06-14

申請人Precision Medical Plastics , Ltd.
決定日期2024-06-14
產品代碼DXT
諮詢委員會履歷
決定相當於

器材摘要

Disposable High-pressure Extension Lines is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical Plastics , Ltd.. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K230668. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable High-pressure Extension Lines?

Disposable High-pressure Extension Lines is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Precision Medical Plastics , Ltd.. The 510(k) number is K230668.

When did Disposable High-pressure Extension Lines receive FDA 510(k) clearance?

Disposable High-pressure Extension Lines received FDA 510(k) clearance on 2024-06-14, under 510(k) number K230668.

Who is the listed applicant for Disposable High-pressure Extension Lines?

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

What is the FDA product code for Disposable High-pressure Extension Lines?

The FDA product code for Disposable High-pressure Extension Lines is DXT.

相關臨床試驗

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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相關器械（代碼：DXT）

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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