FDA 510(k)

CERENOVUS大口径导管；CERENOVUS吸引管套装

K号: K193380 · 2020-07-20

决定日期2020-07-20

产品代码NRY

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2020-07-20 under 510(k) number K193380. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set?

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2020-07-20. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K193380.

When did CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set receive FDA 510(k) clearance?

CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set received FDA 510(k) clearance on 2020-07-20, under 510(k) number K193380.

Who is the listed applicant for CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set?

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

What is the FDA product code for CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set?

The FDA product code for CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set is NRY.

列明Codman & Shurtleff, 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。

K191237CERENOVUS大口径导管 K173192CereLink ICP 传感器基本套件，CereLink ICP 传感器金属颅骨螺栓套件，CereLink ICP 传感器塑料颅骨螺栓套件，CereLink ICP 传感器心室导管套件 K172537Codman EDS 3 CSF外部引流系统，Codman EDS 3 CSF外部引流系统收集袋 K172022CODMAN脑积水阀门、导管及配件（捆绑）K171862GALAXY G3 Mini 微线圈输送系统 K171747MICRUSFRAME 10 抗拉伸微线圈输送系统，MICRUSFRAME 18 抗拉伸微线圈输送系统，DELTAFILL 18 抗拉伸微线圈输送系统，DELTAXSFT 10 抗拉伸微线圈输送系统，GALAXY G3 FILL 和 GALAXY G3 XSFT 抗拉伸微线圈输送系统

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