CERENOVUS 大孔內腸導管
K 號：K191237 · 2019-11-08
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器材摘要
CERENOVUS Large Bore Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K191237. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CERENOVUS Large Bore Catheter?
CERENOVUS Large Bore Catheter is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K191237.
When did CERENOVUS Large Bore Catheter receive FDA 510(k) clearance?
CERENOVUS Large Bore Catheter received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191237.
Who is the listed applicant for CERENOVUS Large Bore Catheter?
The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CERENOVUS Large Bore Catheter?
The FDA product code for CERENOVUS Large Bore Catheter is DQY.
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其他以 Codman & Shurtleff, Inc. 為申請人之記錄
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K193380CERENOVUS 大孔內管；CERENOVUS 吸引管路組K173192CereLink ICP感測器基本套件、CereLink ICP感測器金屬頭蓋螺釘套件、CereLink ICP感測器塑膠頭蓋螺釘套件、CereLink ICP感測器心室針套件K172537科德曼EDS 3 CSF外引流系統，科德曼EDS 3 CSF外引流系統收集袋K172022CODMAN 腦室內腫瘤閥、導管及配件（組裝）K171862GALAXY G3 Mini 微线圈輸送系統K171747MICRUSFRAME 10 拉伸抗力微线圈輸送系統，MICRUSFRAME 18 拉伸抗力微线圈輸送系統，DELTAFILL 18 拉伸抗力微线圈輸送系統，DELTAXSFT 10 拉伸抗力微线圈輸送系統，GALAXY G3 FILL 及 GALAXY G3 XSFT 拉伸抗力微线圈輸送系統
相關器械（代碼：DQY）
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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