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FDA 510(k)

Anchor Dual Lumen 引導導管心臟內腔鏡

K 號：K201076 · 2020-08-06

申請人Aqure Medical, Inc.
決定日期2020-08-06
產品代碼QJP
諮詢委員會履歷
決定相當於

器材摘要

Anchor Dual Lumen Guidewire Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Aqure Medical, Inc.. It received FDA 510(k) clearance on 2020-08-06 under 510(k) number K201076. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Anchor Dual Lumen Guidewire Catheter?

Anchor Dual Lumen Guidewire Catheter is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Aqure Medical, Inc.. The 510(k) number is K201076.

When did Anchor Dual Lumen Guidewire Catheter receive FDA 510(k) clearance?

Anchor Dual Lumen Guidewire Catheter received FDA 510(k) clearance on 2020-08-06, under 510(k) number K201076.

Who is the listed applicant for Anchor Dual Lumen Guidewire Catheter?

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

What is the FDA product code for Anchor Dual Lumen Guidewire Catheter?

The FDA product code for Anchor Dual Lumen Guidewire Catheter is QJP.

相關臨床試驗

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相關器械（代碼：QJP）

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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