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FDA 510(k)

LiquID 061 引導針延伸管，LiquID 071 引導針延伸管

K 號：K220691 · 2022-05-05

申請人Seigla Medical, Inc.
決定日期2022-05-05
產品代碼DQY
諮詢委員會履歷
決定相當於

器材摘要

LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension is the device name listed in this FDA 510(k) record. The listed applicant is Seigla Medical, Inc.. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K220691. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension?

LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Seigla Medical, Inc.. The 510(k) number is K220691.

When did LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension receive FDA 510(k) clearance?

LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension received FDA 510(k) clearance on 2022-05-05, under 510(k) number K220691.

Who is the listed applicant for LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension?

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

What is the FDA product code for LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension?

The FDA product code for LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension is DQY.

相關臨床試驗

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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其他以 Seigla 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。

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相關器械（代碼：DQY）

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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官方來源

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