FDA 510(k)Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
K号: K161464 · 2016-09-30
决定日期2016-09-30
产品代码NLH
咨询委员会CV
决定Substantially Equivalent
器械摘要
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K161464. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters?
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Innovative Health, LLC. The 510(k) number is K161464.
When did Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters receive FDA 510(k) clearance?
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters received FDA 510(k) clearance on 2016-09-30, under 510(k) number K161464.
Who is the listed applicant for Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters?
The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters?
The FDA product code for Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters is NLH.
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列明Innovative Health, LLC为申报人的其他记录
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相关器械（代码：NLH）
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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