FDA 510(k)

CrossBay 子宮頸擴張導尿管系統

K 號：K190813 · 2019-08-23

決定日期2019-08-23

產品代碼PON

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

CrossBay Cervical Dilator Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Crossbay Medical. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K190813. The device is classified under product code PON. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CrossBay Cervical Dilator Catheter System?

CrossBay Cervical Dilator Catheter System is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Crossbay Medical. The 510(k) number is K190813.

When did CrossBay Cervical Dilator Catheter System receive FDA 510(k) clearance?

CrossBay Cervical Dilator Catheter System received FDA 510(k) clearance on 2019-08-23, under 510(k) number K190813.

Who is the listed applicant for CrossBay Cervical Dilator Catheter System?

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

What is the FDA product code for CrossBay Cervical Dilator Catheter System?

The FDA product code for CrossBay Cervical Dilator Catheter System is PON.

其他以 Crossbay Medical 為申請人之記錄

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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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官方來源

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