FDA 510(k)

Venclose digiRF 生成器（VCRFG1）

K号: K250068 · 2025-02-04

决定日期2025-02-04

产品代码GEI

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决定实质等同

器械摘要

Venclose digiRF Generator (VCRFG1) is the device name listed in this FDA 510(k) record. The listed applicant is Venclose, Inc.. It received FDA 510(k) clearance on 2025-02-04 under 510(k) number K250068. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Venclose digiRF Generator (VCRFG1)?

Venclose digiRF Generator (VCRFG1) is a medical device that received FDA 510(k) clearance on 2025-02-04. The listed applicant is Venclose, Inc.. The 510(k) number is K250068.

When did Venclose digiRF Generator (VCRFG1) receive FDA 510(k) clearance?

Venclose digiRF Generator (VCRFG1) received FDA 510(k) clearance on 2025-02-04, under 510(k) number K250068.

Who is the listed applicant for Venclose digiRF Generator (VCRFG1)?

The FDA 510(k) record lists Venclose, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venclose digiRF Generator (VCRFG1)?

The FDA product code for Venclose digiRF Generator (VCRFG1) is GEI.

列明Venclose, 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。

K252316Venclose digiRF 生成器（VCRFG1）；Venclose EVSRF 球囊导管（VC10A256F60，VC10A256F100）K211806Venclose digiRF 生成器与 Maven 导管，Venclose Maven 系统，Venclose digiRF 生成器，Venclose Maven 导管 K160754Venclose 射频系统（digiRF 发生器，EVSRF 电极导管）

相关器械（代码：GEI）

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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