FDA 510(k)

Venclose digiRF 生成器（VCRFG1）；Venclose EVSRF 球囊导管（VC10A256F60，VC10A256F100）

K号: K252316 · 2025-08-19

决定日期2025-08-19

产品代码GEI

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决定实质等同

器械摘要

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is the device name listed in this FDA 510(k) record. The listed applicant is Venclose, Inc.. It received FDA 510(k) clearance on 2025-08-19 under 510(k) number K252316. 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 EVSRF Catheter (VC10A256F60, VC10A256F100)?

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is a medical device that received FDA 510(k) clearance on 2025-08-19. The listed applicant is Venclose, Inc.. The 510(k) number is K252316.

When did Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) receive FDA 510(k) clearance?

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) received FDA 510(k) clearance on 2025-08-19, under 510(k) number K252316.

Who is the listed applicant for Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)?

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); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)?

The FDA product code for Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) 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。

K250068Venclose digiRF 生成器（VCRFG1）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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