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FDA 510(k)

Streamline 6491 雙極兒童臨時起搏導管，Streamline 6492 雙極臨時心房起搏導管，Streamline 6494 雙極臨時心肌起搏電極線，Streamline 6495 雙極臨時心肌起搏導管

K 號：K190716 · 2019-08-08

申請人Medtronic
決定日期2019-08-08
產品代碼LDF
諮詢委員會履歷
決定相當於

器材摘要

Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2019-08-08 under 510(k) number K190716. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead?

Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead is a medical device that received FDA 510(k) clearance on 2019-08-08. The listed applicant is Medtronic. The 510(k) number is K190716.

When did Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead receive FDA 510(k) clearance?

Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead received FDA 510(k) clearance on 2019-08-08, under 510(k) number K190716.

Who is the listed applicant for Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead?

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

What is the FDA product code for Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead?

The FDA product code for Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead is LDF.

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 Medtronic 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。

K253530Trexon™ 单絲合成可吸收縫線K251744Affinity Pixie™ 動脈濾器配平衡™ 生物表面；Affinity® 優幼兒動脈血濾器K233433球體-9Dx 診斷導管 (AFR-00009)K240190MYOtherm XP 心肌停搏液輸送系統搭配 Cortiva 生物活性表面，MYOtherm XP 心肌停搏液輸送系統未包裝K223494CD Horizon脊椎系統K223178SelectSite C304 可調向導管系統，C315 導管輸送系統

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相關器械（代碼：LDF）

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。

K252042同步AV II 暫時性起搏電極Swift Sync, Inc.K242863生物優質雙極起搏電極导管Bioptimal International Pte. , Ltd.K251186Bard® 暫時性起搏電極針/管 (導入器)C.R. Bard, Inc.K241334半浮臨時起搏電極導管，雙極，不鏽鋼電極，115公分，4Fr. (006221P)；半浮臨時起搏電極導管，雙極，不鏽鋼電極，115公分，5Fr. (006225P)；半浮臨時起搏電極導管，雙極，不鏽鋼電極，125公分，6Fr. (006241P)；半浮臨時起搏電極導管，雙極，不鏽鋼電極，125公分，7Fr. (006242P)；NBIH™臨時起搏電極導管，C.R. Bard, Inc.K241199可旋接頭 (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline 雙極兒童臨時起搏導管 (6491) Streamline 雙極臨時心房起搏導管 (6492) Streamline 雙極臨時心肌起搏電極線 (6494) Streamline 雙極臨時心肌起搏導管 (6495) Streamline 雙極臨時心肌起搏導管 (6500)Medtronic, Inc.

官方來源

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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。

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