FDA 510(k)

Cardioblate Gemini-s 49260 外科消融设备；Cardioblate Gemini-s 49351 外科消融设备

K号: K223508 · 2022-12-22

决定日期2022-12-22

产品代码OCL

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决定实质等同

器械摘要

Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2022-12-22 under 510(k) number K223508. 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 Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device?

Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device is a medical device that received FDA 510(k) clearance on 2022-12-22. The listed applicant is Medtronic, Inc.. The 510(k) number is K223508.

When did Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device receive FDA 510(k) clearance?

Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device received FDA 510(k) clearance on 2022-12-22, under 510(k) number K223508.

Who is the listed applicant for Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device?

FDA 510(k)记录中列出Medtronic, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device?

The FDA product code for Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device is OCL.

列明Medtronic, 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。

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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.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.K200514Cardioblate Gemini-s 外科消融设备Medtronic

官方来源

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