免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

BLUperc 皮穿刺擴張氣管造口套件搭配 BLUselect 管子，BLUperc 皮穿刺擴張氣管造口套件搭配 BLUselect 吸痰輔助管，BLUgriggs 皮穿刺擴張氣管造口套件搭配 BLUselect 管子，BLUgriggs 皮穿刺擴張氣管造口套件搭配 BLUselect 吸痰輔助管

K 號：K173912 · 2018-05-08

申請人Smiths Medical Asd, Inc.
決定日期2018-05-08
產品代碼JOH
諮詢委員會AN
決定相當於

器材摘要

BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-05-08 under 510(k) number K173912. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube?

BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube is a medical device that received FDA 510(k) clearance on 2018-05-08. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K173912.

When did BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube receive FDA 510(k) clearance?

BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube received FDA 510(k) clearance on 2018-05-08, under 510(k) number K173912.

Who is the listed applicant for BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube?

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

What is the FDA product code for BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube?

The FDA product code for BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube is JOH.

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

其他以 Smiths Medical Asd, Inc. 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。

K232943皮下針-Pro® EDGE™ 低死空間針筒安全裝置K210833Portex BLUxl 長型氣管切開管，BLUxl 吸痰輔助長型氣管切開管，BLUxl 長型氣管切開管內管K211634皮下針-Pro EDGE 安全設備K192375Intellifuse 藥物給藥及 Intellifuse 靜脈輸注套裝K181699第一級對流加熱器K172800Portex® 鋸刺點脊椎針配NRFit™ 插頭，Portex® 圆錐點脊椎針配NRFit™ 插頭

查看所有 16 項裝置 →

相關器械（代碼：JOH）

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。

K251313Shiley™成人柔軟氣管切開管XLT搭配TaperGuard™袖口，遠端配用一次性內管；Shiley™成人柔軟氣管切開管XLT搭配TaperGuard™袖口，近端配用一次性內管；Shiley™成人柔軟氣管切開管XLT無袖口，遠端配用一次性內管；Shiley™成人柔軟氣管切開管XLT無袖口，近端配用一次性內管；Shiley™成人柔軟一次性內管XLTCovidien, LLCK210833Portex BLUxl 長型氣管切開管，BLUxl 吸痰輔助長型氣管切開管，BLUxl 長型氣管切開管內管Smiths Medical Asd, Inc.K203362TRACOE 適用醫療設備規範文本Tracoe Medical GmbHK193077Shiley成人柔軟擴張氣管切開管，配TaperGuard袖口CovidienK193133藍犀牛G1-多孔經皮氣管造口導入組套，藍犀牛G1-多孔經皮氣管造口導入托盤，藍犀牛G2-多孔經皮氣管造口導入組套，藍犀牛G2-多孔經皮氣管造口導入托盤，威曼-多孔經皮氣管造口交換組套Cook IncorporatedK182861西利兒新生兒/兒童氣管切開管Covidien

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑