FDA 510(k)

心臟燒灼針手術消融裝置，Cardioblate XL 燒灼針手術消融裝置

K 號：K190623 · 2019-05-30

決定日期2019-05-30

產品代碼OCL

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2019-05-30 under 510(k) number K190623. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device?

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device is a medical device that received FDA 510(k) clearance on 2019-05-30. The listed applicant is Medtronic. The 510(k) number is K190623.

When did Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device receive FDA 510(k) clearance?

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device received FDA 510(k) clearance on 2019-05-30, under 510(k) number K190623.

Who is the listed applicant for Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device?

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 Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device?

The FDA product code for Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device is OCL.

其他以 Medtronic 為申請人之記錄

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相關器械（代碼：OCL）

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。

K252056Isolator® Synergy™ EnCompass 鎖定與導引系統（OLH、OSH、GPM100）AtriCure, Inc.K234151隔離協同EnCapture消融系統（EMH）AtriCure, Inc.K221358Isolator® 線性筆 (MLP1)；Isolator® Transpolar™ 筆 (MAX1, MAX5)，Coolrail® 線性筆 (MCR1)；Isolator® Synergy™ 外科消融系統 (EMR2, EML2)；Isolator® Synergy™ EnCompass 鎖釘 (OLH, OSH) 及導引系統；Isolator® Synergy Access 鎖釘 (EMT1)AtriCure, Inc.K223508Cardioblate Gemini-s 49260 外科消融設備；Cardioblate Gemini-s 49351 外科消融設備Medtronic, Inc.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH 驱導磁針AtriCure, Inc.K211311AtriCure Isolator® Synergy™ 外科消融系統AtriCure, Inc.

官方來源

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