FDA 510(k)

心臟冷凝 Gemini-s 外科消融設備

K 號：K200514 · 2020-06-03

決定日期2020-06-03

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 Gemini-s 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 2020-06-03 under 510(k) number K200514. 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 Gemini-s Surgical Ablation Device?

Cardioblate Gemini-s Surgical Ablation Device is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Medtronic. The 510(k) number is K200514.

When did Cardioblate Gemini-s Surgical Ablation Device receive FDA 510(k) clearance?

Cardioblate Gemini-s Surgical Ablation Device received FDA 510(k) clearance on 2020-06-03, under 510(k) number K200514.

Who is the listed applicant for Cardioblate Gemini-s 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 Gemini-s Surgical Ablation Device?

The FDA product code for Cardioblate Gemini-s 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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