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FDA 510(k)

4F Infiniti血管造影导管, 4F & 5F Nylex血管造影导管, 4F & 5F Tempo血管造影导管

K 號:K181836 · 2018-08-08

決定日期2018-08-08
產品代碼DQO
諮詢委員會履歷
決定相當於

器材摘要

4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Cordis, A Cardinal Health Company. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K181836. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters?

4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Cordis, A Cardinal Health Company. The 510(k) number is K181836.

When did 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters receive FDA 510(k) clearance?

4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters received FDA 510(k) clearance on 2018-08-08, under 510(k) number K181836.

Who is the listed applicant for 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters?

The FDA 510(k) record lists Cordis, A Cardinal Health Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters?

The FDA product code for 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters is DQO.

相關臨床試驗

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相關器械(代碼:DQO)

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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