Starlight 成像导管
K号: K243016 · 2025-03-20
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器械摘要
Starlight Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-03-20 under 510(k) number K243016. 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 Starlight Imaging Catheter?
Starlight Imaging Catheter is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Spectrawave, Inc.. The 510(k) number is K243016.
When did Starlight Imaging Catheter receive FDA 510(k) clearance?
Starlight Imaging Catheter received FDA 510(k) clearance on 2025-03-20, under 510(k) number K243016.
Who is the listed applicant for Starlight Imaging Catheter?
The FDA 510(k) record lists Spectrawave, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Starlight Imaging Catheter?
The FDA product code for Starlight Imaging Catheter 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。
列明Spectrawave, 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：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。
K253459OPTIS 移动 Next 成像系统 (1014932)；OPTIS 集成 Next 成像系统 (1014933)；Ultreon 3.0 软件升级套件 (ULTR300001)ABBOTT MEDICALK251730LIA Console (542-7)Leadoptik, Inc.K253101HyperVue™成像系统 - 集成Spectrawave, Inc.K252851deepLive（OSP12 + DMS）Damae MedicalK251198HyperVue™软件Spectrawave, Inc.K250684OPUSWAVE 双传感器成像系统Terumo Cardiovascular Systems Thi Plant
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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