Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
K号: K180086 · 2018-03-08
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器械摘要
常见问题
What is the Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter?
Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K180086.
When did Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter receive FDA 510(k) clearance?
Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter received FDA 510(k) clearance on 2018-03-08, under 510(k) number K180086.
Who is the listed applicant for Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter?
The FDA 510(k) record lists Gyrus Acmi, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter?
The FDA product code for Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter is FGE.
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列明Gyrus Acmi, Inc.为申报人的其他记录
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。
相关器械（代码：FGE）
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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