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FDA 510(k)

NeVap Aspire 子氣管吸痰內氣管管 (ASSET) 配預裝針筒

K 號：K172208 · 2018-02-16

申請人Nevap, Inc.
決定日期2018-02-16
產品代碼BTR
諮詢委員會AN
決定相當於

器材摘要

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is the device name listed in this FDA 510(k) record. The listed applicant is Nevap, Inc.. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K172208. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet?

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Nevap, Inc.. The 510(k) number is K172208.

When did NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet receive FDA 510(k) clearance?

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet received FDA 510(k) clearance on 2018-02-16, under 510(k) number K172208.

Who is the listed applicant for NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet?

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

What is the FDA product code for NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet?

The FDA product code for NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is BTR.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：BTR）

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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