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FDA 510(k)

Avanos* CORTRAK* 2肠内通路系统（EAS）

K号: K220588 · 2022-04-22

申请人Avanos Medical, Inc.
决定日期2022-04-22
产品代码KNT
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

Avanos* CORTRAK* 2 Enteral Access System (EAS) is the device name listed in this FDA 510(k) record. The listed applicant is Avanos Medical, Inc.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K220588. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Avanos* CORTRAK* 2 Enteral Access System (EAS)?

Avanos* CORTRAK* 2 Enteral Access System (EAS) is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K220588.

When did Avanos* CORTRAK* 2 Enteral Access System (EAS) receive FDA 510(k) clearance?

Avanos* CORTRAK* 2 Enteral Access System (EAS) received FDA 510(k) clearance on 2022-04-22, under 510(k) number K220588.

Who is the listed applicant for Avanos* CORTRAK* 2 Enteral Access System (EAS)?

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

What is the FDA product code for Avanos* CORTRAK* 2 Enteral Access System (EAS)?

The FDA product code for Avanos* CORTRAK* 2 Enteral Access System (EAS) is KNT.

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Avanos 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。

K243572Game Ready 系统（550500-04）；Game Ready 控制单元（550550-04）；Game Ready 全腿靴套 - 中号（590923-04）；Game Ready 全腿靴套 - 大号（590922-04）；Game Ready C-T 脊柱套（590502-04）；Game Ready 半腿靴（590906-04）；Game Ready 背部套（590500-04）；Game Ready 手/腕套（590811-04）；Game Ready 弯曲肘部套（590903-04）；Game Ready 直立肘部套（590200-04）；Game Ready 肩部套，中号，右侧（590422-04）；Game Ready 肩部套，LaK241185CORGRIP* SR NG/NI 管道固定系统K242057COOLIEF* 射频发生器（CRG-BASIC，CRG-BASIC-R，CRG-ADVANCED，CRG-ADVANCED-R）K240965CORTRAK* 2 肠内营养通路系统（20-0950）K203066COOLIEF 冷射频套件高级版K192491Coolief射频发生器（CRG）系统

查看所有 8 个设备 →

相关器械（代码：KNT）

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。

K26189052Fr ViSiGi LUX™；52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514明尼苏达四腔食管胃填塞管 - 18 French (0092220)；布莱克莫尔食管鼻胃管 - 20 French (0092100)；布莱克莫尔食管鼻胃管 - 16 French (0092300)C.R. Bard, Inc.K250389XNY一次性胃腔校准管Changzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR（带 ENFit 连接器）ConvatecK242336hygh-tec 排液IIAmb MedtecK242901ZZIREN™ 口胃管；ZZIREN™ SGT 口胃管 - 32 Fr（ZZ-SGT-32）；ZZIREN™ SGT 口胃管 - 36 Fr（ZZ-SGT-36）；ZZIREN™ SGT 口胃管 - 40 Fr（ZZ-SGT-40）；ZZIREN™ GBT 口胃管 - 32 Fr（ZZ-GBT-32）；ZZIREN™ GBT 口胃管 - 36 Fr（ZZ-GBT-36）；ZZIREN™ GBT 口胃管 - 40 Fr（ZZ-GBT-40）Tools For Surgery, LLC

官方来源

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