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FDA 510(k)

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

K号: K252643 · 2026-05-15

申请人Teleflex Medical Sdn. Bhd.
决定日期2026-05-15
产品代码CAH
咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同

器械摘要

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical Sdn. Bhd.. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K252643. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled?

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Teleflex Medical Sdn. Bhd.. The 510(k) number is K252643.

When did Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled receive FDA 510(k) clearance?

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled received FDA 510(k) clearance on 2026-05-15, under 510(k) number K252643.

Who is the listed applicant for Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled?

FDA 510(k)记录将Teleflex Medical Sdn. Bhd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled?

The FDA product code for Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled is CAH.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Teleflex Medical Sdn. Bhd.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。

K262056Rusch 液体金福来尿管K252537Rusch 软塑 Foley 导尿管

相关器械（代码：CAH）

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。

K251583Ambu® Virobac II® 呼气过滤器Ambu A/SK241339Besmed 细菌过滤器和高流量湿化器Besmed Health Business CorpK222917呼吸回路细菌/病毒过滤器Shaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir 气管切开术病毒和细菌气道保护过滤器（PM-APF15）Passy-Muir, Inc.K223258TNI Clear-Guard® 3角位呼吸过滤器（1545020）Intersurgical , Ltd.K221472Filter 和 HME/FilterNingbo Huakun Medical Equipment Co., Ltd.

官方来源

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