FDA 510(k)

cryoICE cryoXT 冷冻消融探头（cryoXT）

K号: K250371 · 2025-04-10

决定日期2025-04-10

产品代码GXH

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决定实质等同

器械摘要

cryoICE cryoXT cryoablation probe (cryoXT) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K250371. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the cryoICE cryoXT cryoablation probe (cryoXT)?

cryoICE cryoXT cryoablation probe (cryoXT) is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is AtriCure, Inc.. The 510(k) number is K250371.

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

cryoICE cryoXT cryoablation probe (cryoXT) received FDA 510(k) clearance on 2025-04-10, under 510(k) number K250371.

Who is the listed applicant for cryoICE cryoXT cryoablation probe (cryoXT)?

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 cryoXT cryoablation probe (cryoXT)?

The FDA product code for cryoICE cryoXT cryoablation probe (cryoXT) is GXH.

列明AtriCure, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252056Isolator®Synergy®EnCompass夹具和引导系统（OLH，OSH，GPM100）K243860AtriClip PRO-Mini LAA Exclusion System (PROM)K243157AtriCure cryoICE BOX (ACM)K234151Isolator Synergy EnCapture消融系统（EMH）K234125AtriClip FLEX-Mini LAA 排除系统 (ACHM)K233959EPi-Ease epicardial access device (EAS)

查看所有 32 个设备 →

相关器械（代码：GXH）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243677iovera° 系统Pacira Biosciences, Inc.K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.K233170cryoICE cryoSPHERE+ 冷冻消融探头（CRYOSP）；cryoICE cryoSPHERE+ 冷冻消融探头（CRYOSP-L）；cryoICE cryoSPHERE MAX 冷冻消融探头（CRYOSMAX）；cryoICE cryoSPHERE MAX 冷冻消融探头（CRYOSMAX-L）AtriCure, Inc.K220656iovera 系统Pacira Biosciences, Inc.K211334Iovera系统Pacira Pharmaceuticals, Inc.K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)AtriCure, Inc.

官方来源

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