FDA 510(k)

AtriCure Isolator® Synergy™ 外科消融系統

K 號：K211311 · 2021-05-28

決定日期2021-05-28

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

AtriCure Isolator® Synergy™ Surgical Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2021-05-28 under 510(k) number K211311. 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 AtriCure Isolator® Synergy™ Surgical Ablation System?

AtriCure Isolator® Synergy™ Surgical Ablation System is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is AtriCure, Inc.. The 510(k) number is K211311.

When did AtriCure Isolator® Synergy™ Surgical Ablation System receive FDA 510(k) clearance?

AtriCure Isolator® Synergy™ Surgical Ablation System received FDA 510(k) clearance on 2021-05-28, under 510(k) number K211311.

Who is the listed applicant for AtriCure Isolator® Synergy™ Surgical Ablation System?

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

What is the FDA product code for AtriCure Isolator® Synergy™ Surgical Ablation System?

The FDA product code for AtriCure Isolator® Synergy™ Surgical Ablation System is OCL.

其他以 AtriCure, Inc. 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。

K252056Isolator® Synergy™ EnCompass 鎖定與導引系統（OLH、OSH、GPM100）K250371cryoICE cryoXT 冷凍消融探針 (cryoXT)K243860AtriClip PRO-Mini LAA 排除系統 (PROM)K243157AtriCure cryoICE BOX (ACM)K234151隔離協同EnCapture消融系統（EMH）K234125AtriClip FLEX-Mini LAA 過濾系統 (ACHM)

查看所有 32 項裝置 →

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.K200514心臟冷凝 Gemini-s 外科消融設備Medtronic

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。