Acclarent NavWire 鼻窦导航导丝
K号: K161697 · 2016-10-24
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决定日期2016-10-24
产品代码PGW
咨询委员会NE
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决定实质等同
器械摘要
Acclarent NavWire Sinus Navigation Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K161697. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Acclarent NavWire Sinus Navigation Guidewire?
Acclarent NavWire Sinus Navigation Guidewire is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is Acclarent, Inc.. The 510(k) number is K161697.
When did Acclarent NavWire Sinus Navigation Guidewire receive FDA 510(k) clearance?
Acclarent NavWire Sinus Navigation Guidewire received FDA 510(k) clearance on 2016-10-24, under 510(k) number K161697.
Who is the listed applicant for Acclarent NavWire Sinus Navigation Guidewire?
The FDA 510(k) record lists Acclarent, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Acclarent NavWire Sinus Navigation Guidewire?
The FDA product code for Acclarent NavWire Sinus Navigation Guidewire is PGW.
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。
列明Acclarent, 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：PGW）
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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