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FDA 510(k)

卡皮弗洛5001

K 號：K222158 · 2023-01-20

申請人K&L Distributing, Inc.
決定日期2023-01-20
產品代碼JOW
諮詢委員會履歷
決定相當於

器材摘要

Capiflo 5001 is the device name listed in this FDA 510(k) record. The listed applicant is K&L Distributing, Inc.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K222158. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Capiflo 5001?

Capiflo 5001 is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is K&L Distributing, Inc.. The 510(k) number is K222158.

When did Capiflo 5001 receive FDA 510(k) clearance?

Capiflo 5001 received FDA 510(k) clearance on 2023-01-20, under 510(k) number K222158.

Who is the listed applicant for Capiflo 5001?

The FDA 510(k) record lists K&L Distributing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capiflo 5001?

The FDA product code for Capiflo 5001 is JOW.

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：JOW）

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。

K261807連續循環器（SC-4004-DL，SC-4008-DL）Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus 進階氣動壓迫系統Tactile MedicalK253386DVT 裝備Vistar Medical Supplies Co., Ltd.K250242壓力治療設備（LGT-2202DVT）Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

官方來源

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