FDA 510(k)

AtriCure cryoICE BOX (ACM)

K号: K243157 · 2024-10-29

决定日期2024-10-29

产品代码GXH

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

AtriCure cryoICE BOX (ACM) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K243157. 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 AtriCure cryoICE BOX (ACM)?

AtriCure cryoICE BOX (ACM) is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is AtriCure, Inc.. The 510(k) number is K243157.

When did AtriCure cryoICE BOX (ACM) receive FDA 510(k) clearance?

AtriCure cryoICE BOX (ACM) received FDA 510(k) clearance on 2024-10-29, under 510(k) number K243157.

Who is the listed applicant for AtriCure cryoICE BOX (ACM)?

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 BOX (ACM)?

The FDA product code for AtriCure cryoICE BOX (ACM) 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）K250371cryoICE cryoXT 冷冻消融探头（cryoXT）K243860AtriClip PRO-Mini LAA Exclusion System (PROM)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。

K250371cryoICE cryoXT 冷冻消融探头（cryoXT）AtriCure, Inc.K243677iovera° 系统Pacira Biosciences, 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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。