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FDA 510(k)

普魯伊特F3頸動脈分流器，10 Fr，普魯伊特F3頸動脈分流器，9 Fr，普魯伊特F3頸動脈分流器，8 Fr

K 號：K182916 · 2018-11-16

申請人Lemaitre Vascular
決定日期2018-11-16
產品代碼MJN
諮詢委員會履歷
決定相當於

器材摘要

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr is the device name listed in this FDA 510(k) record. The listed applicant is Lemaitre Vascular. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K182916. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr?

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Lemaitre Vascular. The 510(k) number is K182916.

When did Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr receive FDA 510(k) clearance?

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr received FDA 510(k) clearance on 2018-11-16, under 510(k) number K182916.

Who is the listed applicant for Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr?

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

What is the FDA product code for Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr?

The FDA product code for Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr is MJN.

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 Lemaitre Vascular 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。

K190882XenoSure 生物貼片K190267EZE SIT 過濾刀

相關器械（代碼：MJN）

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。

K243795pREBOA-PRO 管針Prytime Medical Devices, Inc.K251358橋接加壓氣球（590-002）Philips Image Guided Therapy DevicesK221294preCARDIA 閉塞系統Abiomed, Inc.K214060標誌性REBOA導管Zien Medical Technologies, Inc.K211610福吉蒂塞鎖針管Edwards Lifesciences, LLCK212324RenovoCathRenovorx, Inc.

官方來源

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