FDA 510(k)

BIOTEQ 排液導管 BT-PDS系列

K 號：K210419 · 2022-04-13

決定日期2022-04-13

產品代碼FGE

諮詢委員會GU

決定相當於

器材摘要

BIOTEQ Drainage Catheter BT-PDS-series is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque Corporation. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K210419. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BIOTEQ Drainage Catheter BT-PDS-series?

BIOTEQ Drainage Catheter BT-PDS-series is a medical device that received FDA 510(k) clearance on 2022-04-13. The listed applicant is Bioteque Corporation. The 510(k) number is K210419.

When did BIOTEQ Drainage Catheter BT-PDS-series receive FDA 510(k) clearance?

BIOTEQ Drainage Catheter BT-PDS-series received FDA 510(k) clearance on 2022-04-13, under 510(k) number K210419.

Who is the listed applicant for BIOTEQ Drainage Catheter BT-PDS-series?

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

What is the FDA product code for BIOTEQ Drainage Catheter BT-PDS-series?

The FDA product code for BIOTEQ Drainage Catheter BT-PDS-series is FGE.

其他以 Bioteque Corporation 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：FGE）

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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