Synxess神經血管導絲
K 號：K240871 · 2024-11-18
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器材摘要
Synxess Neurovascular Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Enlight Medical Technologies (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2024-11-18 under 510(k) number K240871. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Synxess Neurovascular Guidewire?
Synxess Neurovascular Guidewire is a medical device that received FDA 510(k) clearance on 2024-11-18. The listed applicant is Enlight Medical Technologies (Shenzhen) Co., Ltd.. The 510(k) number is K240871.
When did Synxess Neurovascular Guidewire receive FDA 510(k) clearance?
Synxess Neurovascular Guidewire received FDA 510(k) clearance on 2024-11-18, under 510(k) number K240871.
Who is the listed applicant for Synxess Neurovascular Guidewire?
The FDA 510(k) record lists Enlight Medical Technologies (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Synxess Neurovascular Guidewire?
The FDA product code for Synxess Neurovascular Guidewire is MOF.
相關臨床試驗
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相關器械（代碼：MOF）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
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