FDA 510(k)Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
K号: K161249 · 2016-08-19
决定日期2016-08-19
产品代码LDF
咨询委员会CV
决定Substantially Equivalent
器械摘要
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K161249. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead?
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Medtronic. The 510(k) number is K161249.
When did Streamline 6495 Bipolar Temporary Myocardial Pacing Lead receive FDA 510(k) clearance?
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead received FDA 510(k) clearance on 2016-08-19, under 510(k) number K161249.
Who is the listed applicant for Streamline 6495 Bipolar Temporary Myocardial Pacing Lead?
The FDA 510(k) record lists Medtronic as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Streamline 6495 Bipolar Temporary Myocardial Pacing Lead?
The FDA product code for Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is LDF.
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列明Medtronic为申报人的其他记录
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相关器械（代码：LDF）
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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