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FDA 510(k)

瓦特森臨時起搏導絲

K 號:K192454 · 2020-01-15

決定日期2020-01-15
產品代碼DQX
諮詢委員會履歷
決定相當於

器材摘要

Wattson Temporary Pacing Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K192454. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wattson Temporary Pacing Guidewire?

Wattson Temporary Pacing Guidewire is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Vascular Solutions. The 510(k) number is K192454.

When did Wattson Temporary Pacing Guidewire receive FDA 510(k) clearance?

Wattson Temporary Pacing Guidewire received FDA 510(k) clearance on 2020-01-15, under 510(k) number K192454.

Who is the listed applicant for Wattson Temporary Pacing Guidewire?

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

What is the FDA product code for Wattson Temporary Pacing Guidewire?

The FDA product code for Wattson Temporary Pacing Guidewire is DQX.

相關臨床試驗

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相關器械(代碼:DQX)

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。

官方來源

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