FDA 510(k)

LungFlow篮状导管

K号: K254040 · 2026-03-12

决定日期2026-03-12

产品代码KTI

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决定实质等同

器械摘要

LungFlow Basket Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Free Flow Medical, Inc.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K254040. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LungFlow Basket Catheter?

LungFlow Basket Catheter is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Free Flow Medical, Inc.. The 510(k) number is K254040.

When did LungFlow Basket Catheter receive FDA 510(k) clearance?

LungFlow Basket Catheter received FDA 510(k) clearance on 2026-03-12, under 510(k) number K254040.

Who is the listed applicant for LungFlow Basket Catheter?

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

What is the FDA product code for LungFlow Basket Catheter?

The FDA product code for LungFlow Basket Catheter is KTI.

列明Free Flow Medical, 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。

K254037LungFlow气道导管

相关器械（代码：KTI）

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。

K261274EchoTip Ultra® 内镜超声活检针，适用于富士胶片内窥镜；EchoTip ProCore® 内镜超声活检针，适用于富士胶片内窥镜Cook Ireland, Ltd.K251478ClearTip TBNA 类型Finemedix Co., Ltd.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass可调针，配备适配器SRA-1-01和SRA-2-01Serpex Medical, Inc.K251664一次性吸引针（NA-201SX-4021）；一次性吸引针（NA-201SX-4022）Olympus Medical Systems Corporation K250263一次性抓持镊FG-52D/FG-54DOlympus Medical Systems Corp.

官方来源

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