FDA 510(k)

BAROnova Access Sheath Kit

K 號：K191078 · 2019-07-22

決定日期2019-07-22

產品代碼QGG

諮詢委員會GU

決定Unknown

器材摘要

BAROnova Access Sheath Kit is the device name listed in this FDA 510(k) record. The listed applicant is Baronova, Inc.. It received FDA 510(k) clearance on 2019-07-22 under 510(k) number K191078. The device is classified under product code QGG. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the BAROnova Access Sheath Kit?

BAROnova Access Sheath Kit is a medical device that received FDA 510(k) clearance on 2019-07-22. The listed applicant is Baronova, Inc.. The 510(k) number is K191078.

When did BAROnova Access Sheath Kit receive FDA 510(k) clearance?

BAROnova Access Sheath Kit received FDA 510(k) clearance on 2019-07-22, under 510(k) number K191078.

Who is the listed applicant for BAROnova Access Sheath Kit?

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

What is the FDA product code for BAROnova Access Sheath Kit?

The FDA product code for BAROnova Access Sheath Kit is QGG.

其他以 Baronova, 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。

K190985BAROnova 空氣注入系統，BAROnova 道具套件 K172575BAROnova 擷取套件，BAROnova 開放管，BAROnova 経驗帽

官方來源

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器材摘要

常見問題

相關臨床試驗

其他以 Baronova, Inc. 為申請人之記錄

官方來源