FDA 510(k)

真流閉孔成形灌流心导管

K 號：K172932 · 2017-12-13

決定日期2017-12-13

產品代碼OZT

諮詢委員會履歷

決定相當於

器材摘要

True Flow Valvuloplasty Perfusion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2017-12-13 under 510(k) number K172932. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the True Flow Valvuloplasty Perfusion Catheter?

True Flow Valvuloplasty Perfusion Catheter is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K172932.

When did True Flow Valvuloplasty Perfusion Catheter receive FDA 510(k) clearance?

True Flow Valvuloplasty Perfusion Catheter received FDA 510(k) clearance on 2017-12-13, under 510(k) number K172932.

Who is the listed applicant for True Flow Valvuloplasty Perfusion Catheter?

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

What is the FDA product code for True Flow Valvuloplasty Perfusion Catheter?

The FDA product code for True Flow Valvuloplasty Perfusion Catheter is OZT.

其他以 C.R. Bard, 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：OZT）

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。

K253855KardiaPSI 气球心导管Intervention Tech, Inc. ; dba Corvention K260437心瓣膜成形氣球导管（ValvuloPro）Dongguan TT Medical, Inc.K241562OutFlo 鳩膝瓣擴張氣球針管Disa Medinotec K240967ValvuloPro 門腔擴張氣球針管Dongguan TT Medical, Inc.K231814ValvuloPro 門腔擴張氣球針管Dongguan TT Medical, Inc.K220881伊野內氣球AToray Industries, Inc.

官方來源

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