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FDA 510(k)

自動持續滲出分流器系統 (ACES) 系統 ACES 系統

K 號：K231096 · 2023-08-18

申請人Pleural Dynamics, Inc.
決定日期2023-08-18
產品代碼KPM
諮詢委員會GU
決定相當於

器材摘要

Automatic Continuous Effusion Shunt (ACES) System ACES System is the device name listed in this FDA 510(k) record. The listed applicant is Pleural Dynamics, Inc.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231096. The device is classified under product code KPM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Automatic Continuous Effusion Shunt (ACES) System ACES System?

Automatic Continuous Effusion Shunt (ACES) System ACES System is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Pleural Dynamics, Inc.. The 510(k) number is K231096.

When did Automatic Continuous Effusion Shunt (ACES) System ACES System receive FDA 510(k) clearance?

Automatic Continuous Effusion Shunt (ACES) System ACES System received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231096.

Who is the listed applicant for Automatic Continuous Effusion Shunt (ACES) System ACES System?

The FDA 510(k) record lists Pleural Dynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Automatic Continuous Effusion Shunt (ACES) System ACES System?

The FDA product code for Automatic Continuous Effusion Shunt (ACES) System ACES System is KPM.

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：KPM）

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。

K170405BD Curve 腹水分流器Care Fusion

官方來源

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