FDA 510(k)

JMS CAVEO A.V. 肛门瘘管针套装

K号: K251877 · 2025-08-15

决定日期2025-08-15

产品代码FIE

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

JMS CAVEO A.V. Fistula Needle Set is the device name listed in this FDA 510(k) record. The listed applicant is JMS North America Corporation. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K251877. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the JMS CAVEO A.V. Fistula Needle Set?

JMS CAVEO A.V. Fistula Needle Set is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is JMS North America Corporation. The 510(k) number is K251877.

When did JMS CAVEO A.V. Fistula Needle Set receive FDA 510(k) clearance?

JMS CAVEO A.V. Fistula Needle Set received FDA 510(k) clearance on 2025-08-15, under 510(k) number K251877.

Who is the listed applicant for JMS CAVEO A.V. Fistula Needle Set?

The FDA 510(k) record lists JMS North America Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JMS CAVEO A.V. Fistula Needle Set?

The FDA product code for JMS CAVEO A.V. Fistula Needle Set is FIE.

列明JMS North America Corporation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。

K172499NEOSHIELD

相关器械（代码：FIE）

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。

K253469Ritus™ 安全瘘管导管带防反流阀 15G x 30mm（1530VSMM）；Ritus™ 安全瘘管导管带防反流阀 15G x 38mm（1538VSMM）；Ritus™ 安全瘘管导管带防反流阀 16G x 30mm（1630VSMM）；Ritus™ 安全瘘管导管带防反流阀 16G x 38mm（1638VSMM）；Ritus™ 安全瘘管导管带防反流阀 17G x 30mm（1730VSMM）；Ritus™ 安全瘘管导管带防反流阀 17G x 38mm（1738VSMM）Mozarc Medical Us, LLC K213015DORA一次性A.V.瘘管针套装Bain Medical Equipment (Guangzhou) Co., Ltd.K171505Dimesol一次性AV瘘管针套装（非安全系列）和Dimesol一次性AV瘘管针套装（安全系列）Dimesol, Inc.K163025DORA一次性A.V.瘘管针套装Bain Medical Equipment (Guangzhou) Co., Ltd.

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。