FDA 510(k)

AtriCure Isolator® Synergy™ Surgical Ablation System

K号: K211311 · 2021-05-28

决定日期2021-05-28

产品代码OCL

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决定实质等同

器械摘要

AtriCure Isolator® Synergy™ Surgical Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2021-05-28 under 510(k) number K211311. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AtriCure Isolator® Synergy™ Surgical Ablation System?

AtriCure Isolator® Synergy™ Surgical Ablation System is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is AtriCure, Inc.. The 510(k) number is K211311.

When did AtriCure Isolator® Synergy™ Surgical Ablation System receive FDA 510(k) clearance?

AtriCure Isolator® Synergy™ Surgical Ablation System received FDA 510(k) clearance on 2021-05-28, under 510(k) number K211311.

Who is the listed applicant for AtriCure Isolator® Synergy™ Surgical Ablation System?

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 Isolator® Synergy™ Surgical Ablation System?

The FDA product code for AtriCure Isolator® Synergy™ Surgical Ablation System is OCL.

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)K243157AtriCure cryoICE BOX (ACM)K234151Isolator Synergy EnCapture消融系统（EMH）K234125AtriClip FLEX-Mini LAA 排除系统 (ACHM)

查看所有 32 个设备 →

相关器械（代码：OCL）

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）AtriCure, Inc.K234151Isolator Synergy EnCapture消融系统（EMH）AtriCure, Inc.K221358Isolator®线性笔（MLP1）；Isolator®Transpolar®笔（MAX1，MAX5），Coolrail®线性笔（MCR1）；Isolator®Synergy手术消融系统（EMR2，EML2）；Isolator®Synergy®EnCompass夹具（OLH，OSH）和引导系统；Isolator®Synergy Access夹具（EMT1）AtriCure, Inc.K223508Cardioblate Gemini-s 49260 外科消融设备；Cardioblate Gemini-s 49351 外科消融设备Medtronic, Inc.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K200514Cardioblate Gemini-s 外科消融设备Medtronic

官方来源

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