FDA 510(k)

AEROmini Ǹ

K号: K181200 · 2018-09-21

决定日期2018-09-21

产品代码JCT

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决定实质等同

器械摘要

AEROmini Tracheobronchial Stent System 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 2018-09-21 under 510(k) number K181200. The device is classified under product code JCT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AEROmini Tracheobronchial Stent System?

AEROmini Tracheobronchial Stent System is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K181200.

When did AEROmini Tracheobronchial Stent System receive FDA 510(k) clearance?

AEROmini Tracheobronchial Stent System received FDA 510(k) clearance on 2018-09-21, under 510(k) number K181200.

Who is the listed applicant for AEROmini Tracheobronchial Stent System?

FDA 510(k)记录中列出了Merit Medical Systems, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for AEROmini Tracheobronchial Stent System?

The FDA product code for AEROmini Tracheobronchial Stent System is JCT.

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。

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