Pirouette 035
K 號：K161427 · 2016-07-30
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器材摘要
Pirouette 035 is the device name listed in this FDA 510(k) record. The listed applicant is Arravasc Limited. It received FDA 510(k) clearance on 2016-07-30 under 510(k) number K161427. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Pirouette 035?
Pirouette 035 is a medical device that received FDA 510(k) clearance on 2016-07-30. The listed applicant is Arravasc Limited. The 510(k) number is K161427.
When did Pirouette 035 receive FDA 510(k) clearance?
Pirouette 035 received FDA 510(k) clearance on 2016-07-30, under 510(k) number K161427.
Who is the listed applicant for Pirouette 035?
The FDA 510(k) record lists Arravasc Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pirouette 035?
The FDA product code for Pirouette 035 is LIT.
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相關器械（代碼：LIT）
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。
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官方來源
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