FDA 510(k)

AtriCure cryoICE 冷凍消融探針 (Cryo2), AAtriCure cryoICE 冷凍SPHERE 冷凍消融探針 (CryoS, CryoS-L)

K 號：K200697 · 2020-12-23

決定日期2020-12-23

產品代碼GXH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K200697. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)?

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is AtriCure, Inc.. The 510(k) number is K200697.

When did AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) receive FDA 510(k) clearance?

AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) received FDA 510(k) clearance on 2020-12-23, under 510(k) number K200697.

Who is the listed applicant for AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)?

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 cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)?

The FDA product code for AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) is GXH.

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：GXH）

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。

K250371cryoICE cryoXT 冷凍消融探針 (cryoXT)AtriCure, Inc.K243677iovera° 系統Pacira Biosciences, Inc.K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.K233170cryoICE cryoSPHERE+ 冷凍消融探針 (CRYOSP)；cryoICE cryoSPHERE+ 冷凍消融探針 (CRYOSP-L)；cryoICE cryoSPHERE MAX 冷凍消融探針 (CRYOSMAX)；cryoICE cryoSPHERE MAX 冷凍消融探針 (CRYOSMAX-L)AtriCure, Inc.K220656iovera 系統Pacira Biosciences, Inc.K211334Iovera 系統Pacira Pharmaceuticals, Inc.

官方來源

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