CrossBay 颈管扩张器导管系统
K号: K190813 · 2019-08-23
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决定日期2019-08-23
产品代码PON
咨询委员会OB
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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列明Crossbay Medical为申报人的其他记录
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相关器械（代码：PON）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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