免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

預防套件

K 號：K232379 · 2024-02-05

申請人Clear Choice Therapeutics
決定日期2024-02-05
產品代碼OMP
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

PREVENT Kit is the device name listed in this FDA 510(k) record. The listed applicant is Clear Choice Therapeutics. It received FDA 510(k) clearance on 2024-02-05 under 510(k) number K232379. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PREVENT Kit?

PREVENT Kit is a medical device that received FDA 510(k) clearance on 2024-02-05. The listed applicant is Clear Choice Therapeutics. The 510(k) number is K232379.

When did PREVENT Kit receive FDA 510(k) clearance?

PREVENT Kit received FDA 510(k) clearance on 2024-02-05, under 510(k) number K232379.

Who is the listed applicant for PREVENT Kit?

The FDA 510(k) record lists Clear Choice Therapeutics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREVENT Kit?

The FDA product code for PREVENT Kit is OMP.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：OMP）

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。

K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 負壓傷口治療系統Convatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 內容器 500-mL (CPC-500)Cork MedicalK254019傷口基因NPWT系統Bechtel Medical, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑