FDA 510(k)

ELISIO™-H

K号: K260533 · 2026-03-19

决定日期2026-03-19

产品代码KDI

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决定实质等同

器械摘要

ELISIO™-H is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2026-03-19 under 510(k) number K260533. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ELISIO™-H?

ELISIO™-H is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is Nipro Medical Corporation. The 510(k) number is K260533.

When did ELISIO™-H receive FDA 510(k) clearance?

ELISIO™-H received FDA 510(k) clearance on 2026-03-19, under 510(k) number K260533.

Who is the listed applicant for ELISIO™-H?

FDA 510(k)记录中列出了Nipro Medical Corporation为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for ELISIO™-H?

The FDA product code for ELISIO™-H is KDI.

列明Nipro Medical 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。

K261399ELISIO™-HX K253047PRESSONE™K222852尼普洛 SafeTouch 针头；尼普洛注射器和 SafeTouch 针头 K212677aboNT 注射器 K190037Cronus HP PTA Balloon Catheter K191359尼普洛注射器

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相关器械（代码：KDI）

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。

K261267Careflux H60；Careflux H70；Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC K252459multiFlux 130（F00013123）；multiFlux 160（F00013124）Fresenius Medical Care Renal Therapies Group, LLC K253412Tablo血液透析系统（PN-0008000，PN-0006000U）Outset Medical, Inc.K253518FX CorAL 40；FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC K243920Purema H Hemoconcentrator - PediatricMedica USA, Inc.

官方来源

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