FDA 510(k)

ValvuloPro 門腔擴張氣球針管

K 號：K240967 · 2024-07-31

決定日期2024-07-31

產品代碼OZT

諮詢委員會履歷

決定相當於

器材摘要

ValvuloPro Valvuloplasty Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan TT Medical, Inc.. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K240967. 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 ValvuloPro Valvuloplasty Balloon Catheter?

ValvuloPro Valvuloplasty Balloon Catheter is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Dongguan TT Medical, Inc.. The 510(k) number is K240967.

When did ValvuloPro Valvuloplasty Balloon Catheter receive FDA 510(k) clearance?

ValvuloPro Valvuloplasty Balloon Catheter received FDA 510(k) clearance on 2024-07-31, under 510(k) number K240967.

Who is the listed applicant for ValvuloPro Valvuloplasty Balloon Catheter?

The FDA 510(k) record lists Dongguan TT Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ValvuloPro Valvuloplasty Balloon Catheter?

The FDA product code for ValvuloPro Valvuloplasty Balloon Catheter is OZT.

其他以 Dongguan TT Medical, 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。

K260437心瓣膜成形氣球导管（ValvuloPro）K231814ValvuloPro 門腔擴張氣球針管 K230374心臟擴張氣球針筒（VesPenetrator®）、心臟擴張氣球針筒（VesTraveler®）、心臟擴張氣球針筒（VexPander®）K222663多階段氣球擴張導管 K222187多階段氣球擴張導管

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 K231814ValvuloPro 門腔擴張氣球針管Dongguan TT Medical, Inc.K220881伊野內氣球AToray Industries, Inc.K172932真流閉孔成形灌流心导管C.R. Bard, 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。