Stratus 渗透針管
K 號：K222185 · 2023-04-13
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器材摘要
Stratus Infusion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Intervene, Inc.. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K222185. The device is classified under product code NPG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Stratus Infusion Catheter?
Stratus Infusion Catheter is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Intervene, Inc.. The 510(k) number is K222185.
When did Stratus Infusion Catheter receive FDA 510(k) clearance?
Stratus Infusion Catheter received FDA 510(k) clearance on 2023-04-13, under 510(k) number K222185.
Who is the listed applicant for Stratus Infusion Catheter?
The FDA 510(k) record lists Intervene, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stratus Infusion Catheter?
The FDA product code for Stratus Infusion Catheter is NPG.
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官方來源
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