CORTRAK* 2 肠内营养通路系统（20-0950）
K号: K240965 · 2024-06-06
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决定日期2024-06-06
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
CORTRAK* 2 Enteral Access System (20-0950) 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 2024-06-06 under 510(k) number K240965. 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 CORTRAK* 2 Enteral Access System (20-0950)?
CORTRAK* 2 Enteral Access System (20-0950) is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K240965.
When did CORTRAK* 2 Enteral Access System (20-0950) receive FDA 510(k) clearance?
CORTRAK* 2 Enteral Access System (20-0950) received FDA 510(k) clearance on 2024-06-06, under 510(k) number K240965.
Who is the listed applicant for CORTRAK* 2 Enteral Access System (20-0950)?
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 CORTRAK* 2 Enteral Access System (20-0950)?
The FDA product code for CORTRAK* 2 Enteral Access System (20-0950) 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。
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）K220588Avanos* CORTRAK* 2肠内通路系统（EAS）K203066COOLIEF 冷射频套件高级版K192491Coolief射频发生器（CRG）系统
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。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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