表面內外進入導管系統
K 號：K252527 · 2025-09-10
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器材摘要
Surfacer Inside-Out Access Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical System, Inc.. It received FDA 510(k) clearance on 2025-09-10 under 510(k) number K252527. The device is classified under product code QJH. It was reviewed by the CV advisory panel. FDA Decision: Unknown.
常見問題
What is the Surfacer Inside-Out Access Catheter System?
Surfacer Inside-Out Access Catheter System is a medical device that received FDA 510(k) clearance on 2025-09-10. The listed applicant is Merit Medical System, Inc.. The 510(k) number is K252527.
When did Surfacer Inside-Out Access Catheter System receive FDA 510(k) clearance?
Surfacer Inside-Out Access Catheter System received FDA 510(k) clearance on 2025-09-10, under 510(k) number K252527.
Who is the listed applicant for Surfacer Inside-Out Access Catheter System?
The FDA 510(k) record lists Merit Medical System, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Surfacer Inside-Out Access Catheter System?
The FDA product code for Surfacer Inside-Out Access Catheter System is QJH.
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其他以 Merit Medical System, Inc. 為申請人之記錄
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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