EasyPass 导丝
K号: K153264 · 2016-05-19
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决定日期2016-05-19
产品代码OCY
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
EasyPass Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Globe Corporation. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K153264. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EasyPass Guidewire?
EasyPass Guidewire is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Medi-Globe Corporation. The 510(k) number is K153264.
When did EasyPass Guidewire receive FDA 510(k) clearance?
EasyPass Guidewire received FDA 510(k) clearance on 2016-05-19, under 510(k) number K153264.
Who is the listed applicant for EasyPass Guidewire?
The FDA 510(k) record lists Medi-Globe Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EasyPass Guidewire?
The FDA product code for EasyPass Guidewire is OCY.
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