FDA 510(k)

EDEN ControlCath

K号: K241410 · 2025-02-13

决定日期2025-02-13

产品代码BSO

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决定实质等同

器械摘要

EDEN ControlCath is the device name listed in this FDA 510(k) record. The listed applicant is Jmt Co., Ltd.. It received FDA 510(k) clearance on 2025-02-13 under 510(k) number K241410. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EDEN ControlCath?

EDEN ControlCath is a medical device that received FDA 510(k) clearance on 2025-02-13. The listed applicant is Jmt Co., Ltd.. The 510(k) number is K241410.

When did EDEN ControlCath receive FDA 510(k) clearance?

EDEN ControlCath received FDA 510(k) clearance on 2025-02-13, under 510(k) number K241410.

Who is the listed applicant for EDEN ControlCath?

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

What is the FDA product code for EDEN ControlCath?

The FDA product code for EDEN ControlCath is BSO.

列明Jmt Co., Ltd.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。

K230762EDEN 脊柱固定微创系统 K201788EDEN 脊柱固定系统 K201793EDEN Peek Cage

相关器械（代码：BSO）

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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官方来源

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