病人專屬氣道支架
K 號：K182743 · 2019-10-23
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器材摘要
Patient-Specific Airway Stent is the device name listed in this FDA 510(k) record. The listed applicant is New Cos, Inc.. It received FDA 510(k) clearance on 2019-10-23 under 510(k) number K182743. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Patient-Specific Airway Stent?
Patient-Specific Airway Stent is a medical device that received FDA 510(k) clearance on 2019-10-23. The listed applicant is New Cos, Inc.. The 510(k) number is K182743.
When did Patient-Specific Airway Stent receive FDA 510(k) clearance?
Patient-Specific Airway Stent received FDA 510(k) clearance on 2019-10-23, under 510(k) number K182743.
Who is the listed applicant for Patient-Specific Airway Stent?
The FDA 510(k) record lists New Cos, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Patient-Specific Airway Stent?
The FDA product code for Patient-Specific Airway Stent is NWA.
相關臨床試驗
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相關器械（代碼：NWA）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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