FDA 510(k)

cryoFORM cryoICE 冷凍消融探針

K 號：K152337 · 2016-03-22

決定日期2016-03-22

產品代碼GEH

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

cryoFORM cryoICE cryoablation probe is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2016-03-22 under 510(k) number K152337. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the cryoFORM cryoICE cryoablation probe?

cryoFORM cryoICE cryoablation probe is a medical device that received FDA 510(k) clearance on 2016-03-22. The listed applicant is AtriCure, Inc.. The 510(k) number is K152337.

When did cryoFORM cryoICE cryoablation probe receive FDA 510(k) clearance?

cryoFORM cryoICE cryoablation probe received FDA 510(k) clearance on 2016-03-22, under 510(k) number K152337.

Who is the listed applicant for cryoFORM cryoICE cryoablation probe?

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 cryoFORM cryoICE cryoablation probe?

The FDA product code for cryoFORM cryoICE cryoablation probe is GEH.

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)

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相關器械（代碼：GEH）

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。

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官方來源

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