FDA 510(k)

CERENOVUS大口径导管

K号: K191237 · 2019-11-08

决定日期2019-11-08

产品代码DQY

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 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 2019-11-08 under 510(k) number K191237. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CERENOVUS Large Bore Catheter?

CERENOVUS Large Bore Catheter is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K191237.

When did CERENOVUS Large Bore Catheter receive FDA 510(k) clearance?

CERENOVUS Large Bore Catheter received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191237.

Who is the listed applicant for CERENOVUS Large Bore Catheter?

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?

The FDA product code for CERENOVUS Large Bore Catheter is DQY.

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。

K193380CERENOVUS大口径导管；CERENOVUS吸引管套装 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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