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)

全導引矽膠福樸導尿管，配備溫度感測器

K 號：K202134 · 2021-04-08

申請人Well Lead Medical Co., Ltd.
決定日期2021-04-08
產品代碼EZL
諮詢委員會GU
決定相當於

器材摘要

Well Lead All Silicone Foley Catheter with Temperature Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-04-08 under 510(k) number K202134. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Well Lead All Silicone Foley Catheter with Temperature Sensor?

Well Lead All Silicone Foley Catheter with Temperature Sensor is a medical device that received FDA 510(k) clearance on 2021-04-08. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K202134.

When did Well Lead All Silicone Foley Catheter with Temperature Sensor receive FDA 510(k) clearance?

Well Lead All Silicone Foley Catheter with Temperature Sensor received FDA 510(k) clearance on 2021-04-08, under 510(k) number K202134.

Who is the listed applicant for Well Lead All Silicone Foley Catheter with Temperature Sensor?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Well Lead All Silicone Foley Catheter with Temperature Sensor?

The FDA product code for Well Lead All Silicone Foley Catheter with Temperature Sensor is EZL.

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 Well Lead Medical Co., Ltd. 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。

K241734Wellead® 水性間歇性導尿管 預先使用型；Wellead® 水性間歇性導尿管 簡易型K220722PVC親水性尿道導尿管K220036Wellead 腎管導尿管K211543魏鼻噴管K211814Wellead內視鏡密封圈K203119ClearPetra 吸排式套管

查看所有 12 項裝置 →

相關器械（代碼：EZL）

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。

K260756TraumaGuard 腹腔內壓力感知系統 (000-0221)Sentinel Medical Technologies,K262056魯士拉特克斯金福樓伊姆導尿管Teleflex Medical Sdn. Bhd.K252537魯士軟簡塑福樸利氧導管Teleflex Medical Sdn. Bhd.K243011矽膠尿道導尿管（矽膠尿道導尿管）Guangdong Ecan Medical Co., Ltd.K241424InnoCare 專業福爾伊灌腸器Innocare Urologics, LLCK232469魯施天然乳膠金屬福樸導尿管Teleflexmedical, Inc.

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。

↑