Achieve Advance Mapping Catheter
K 號：K162892 · 2016-11-15
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器材摘要
Achieve Advance Mapping Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K162892. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Achieve Advance Mapping Catheter?
Achieve Advance Mapping Catheter is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Medtronic, Inc.. The 510(k) number is K162892.
When did Achieve Advance Mapping Catheter receive FDA 510(k) clearance?
Achieve Advance Mapping Catheter received FDA 510(k) clearance on 2016-11-15, under 510(k) number K162892.
Who is the listed applicant for Achieve Advance Mapping Catheter?
The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Achieve Advance Mapping Catheter?
The FDA product code for Achieve Advance Mapping Catheter is DRF.
相關臨床試驗
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其他以 Medtronic, 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。
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相關器械（代碼：DRF）
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。
K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.
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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