FDA 510(k)重製顧問FL環形映射導管，感測器啟用
K 號：K200205 · 2020-05-13
決定日期2020-05-13
產品代碼NLH
諮詢委員會履歷
決定相當於
器材摘要
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2020-05-13 under 510(k) number K200205. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is a medical device that received FDA 510(k) clearance on 2020-05-13. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K200205.
When did Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled receive FDA 510(k) clearance?
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled received FDA 510(k) clearance on 2020-05-13, under 510(k) number K200205.
Who is the listed applicant for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?
The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?
The FDA product code for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is NLH.
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其他以 Stryker Sustainability Solutions 為申請人之記錄
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相關器械（代碼：NLH）
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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