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FDA 510(k)

GlidePath 長期血液透析針管，HemoStar 長期血液透析針管，HemoStar XK 長期血液透析針管

K 號：K190527 · 2020-03-05

申請人C. R. Bard
決定日期2020-03-05
產品代碼MSD
諮詢委員會GU
決定Unknown

器材摘要

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters is the device name listed in this FDA 510(k) record. The listed applicant is C. R. Bard. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K190527. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters?

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is C. R. Bard. The 510(k) number is K190527.

When did GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters receive FDA 510(k) clearance?

GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters received FDA 510(k) clearance on 2020-03-05, under 510(k) number K190527.

Who is the listed applicant for GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters?

The FDA 510(k) record lists C. R. Bard as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters?

The FDA product code for GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters is MSD.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 C. R. Bard 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：MSD）

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。

K241581血液透析針管Haolang Medical USA CorporationK210461終端蓋Medical Components Inc (Medcomp)K203575GlidePath 長期血液透析導管C.R. Bard, Inc.K211410GlidePath 13F 長期血液透析針管Bard Peripheral Vascular, Inc.K203767純淨長期血液透析針管C B Bard, Inc.K202150GlidePath 7.5F 長期透析針管C.R. Bard, Inc.

官方來源

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