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FDA 510(k)

cryoICE 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)

K 號：K233170 · 2023-10-26

申請人AtriCure, Inc.
決定日期2023-10-26
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

cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-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 2023-10-26 under 510(k) number K233170. 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 cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)?

cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is AtriCure, Inc.. The 510(k) number is K233170.

When did cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) receive FDA 510(k) clearance?

cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) received FDA 510(k) clearance on 2023-10-26, under 510(k) number K233170.

Who is the listed applicant for cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-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 cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)?

The FDA product code for cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) is GXH.

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 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.K220656iovera 系統Pacira Biosciences, Inc.K211334Iovera 系統Pacira Pharmaceuticals, Inc.K200697AtriCure cryoICE 冷凍消融探針 (Cryo2), AAtriCure cryoICE 冷凍SPHERE 冷凍消融探針 (CryoS, CryoS-L)AtriCure, Inc.

官方來源

在 FDA 資料庫中查看 →

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