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FDA 510(k)

經皮導入針

K 號:K191295 · 2019-08-06

決定日期2019-08-06
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

Percutaneous Introducer Needle is the device name listed in this FDA 510(k) record. The listed applicant is Progressive Medical, Inc.. It received FDA 510(k) clearance on 2019-08-06 under 510(k) number K191295. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Percutaneous Introducer Needle?

Percutaneous Introducer Needle is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Progressive Medical, Inc.. The 510(k) number is K191295.

When did Percutaneous Introducer Needle receive FDA 510(k) clearance?

Percutaneous Introducer Needle received FDA 510(k) clearance on 2019-08-06, under 510(k) number K191295.

Who is the listed applicant for Percutaneous Introducer Needle?

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

What is the FDA product code for Percutaneous Introducer Needle?

The FDA product code for Percutaneous Introducer Needle is GCJ.

相關臨床試驗

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相關器械(代碼:GCJ)

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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