FDA 510(k)

再製Agilis NxT可導引導管

K 號：K230376 · 2023-08-07

決定日期2023-08-07

產品代碼PNE

諮詢委員會履歷

決定相當於

器材摘要

Reprocessed Agilis NxT Steerable Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2023-08-07 under 510(k) number K230376. The device is classified under product code PNE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reprocessed Agilis NxT Steerable Introducer?

Reprocessed Agilis NxT Steerable Introducer is a medical device that received FDA 510(k) clearance on 2023-08-07. The listed applicant is Innovative Health, LLC. The 510(k) number is K230376.

When did Reprocessed Agilis NxT Steerable Introducer receive FDA 510(k) clearance?

Reprocessed Agilis NxT Steerable Introducer received FDA 510(k) clearance on 2023-08-07, under 510(k) number K230376.

Who is the listed applicant for Reprocessed Agilis NxT Steerable Introducer?

The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed Agilis NxT Steerable Introducer?

The FDA product code for Reprocessed Agilis NxT Steerable Introducer is PNE.

其他以 Innovative Health, LLC 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：PNE）

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。

K250305再製Agilis NxT可導引導管Innovative Health K250314Medline ReNewal 再生 Abbott Agilis Nxt 可導引引入器Surgical Instrument Service and Savings, Inc.K232037重製 VersaCross 操控導管；重製 SureFlex 操控導引導管Innovative Health, LLC K212165重製 Carto Vizigo 兩向導引鞘Innovative Health, LLC K170311再製Agilis NxT可導引導管Innovative Health, LLC K152090再處理可導引導管Sterilmed, Inc.

官方來源

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