OPTIS 金属支架优化 E.4 SW
K号: K160878 · 2016-06-29
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器械摘要
OPTIS Metallic Stent Optimization E.4 SW is the device name listed in this FDA 510(k) record. The listed applicant is Lightlab Imaging, Inc.. It received FDA 510(k) clearance on 2016-06-29 under 510(k) number K160878. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OPTIS Metallic Stent Optimization E.4 SW?
OPTIS Metallic Stent Optimization E.4 SW is a medical device that received FDA 510(k) clearance on 2016-06-29. The listed applicant is Lightlab Imaging, Inc.. The 510(k) number is K160878.
When did OPTIS Metallic Stent Optimization E.4 SW receive FDA 510(k) clearance?
OPTIS Metallic Stent Optimization E.4 SW received FDA 510(k) clearance on 2016-06-29, under 510(k) number K160878.
Who is the listed applicant for OPTIS Metallic Stent Optimization E.4 SW?
The FDA 510(k) record lists Lightlab Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OPTIS Metallic Stent Optimization E.4 SW?
The FDA product code for OPTIS Metallic Stent Optimization E.4 SW is NQQ.
相关临床试验
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：NQQ）
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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