Elation Pulmonary Balloon Dilation
K号: K161392 · 2016-09-01
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器械摘要
Elation Pulmonary Balloon Dilation is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K161392. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Elation Pulmonary Balloon Dilation?
Elation Pulmonary Balloon Dilation is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K161392.
When did Elation Pulmonary Balloon Dilation receive FDA 510(k) clearance?
Elation Pulmonary Balloon Dilation received FDA 510(k) clearance on 2016-09-01, under 510(k) number K161392.
Who is the listed applicant for Elation Pulmonary Balloon Dilation?
The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Elation Pulmonary Balloon Dilation?
The FDA product code for Elation Pulmonary Balloon Dilation is KTI.
相关临床试验
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列明Merit Medical Systems, 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：KTI）
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。
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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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