FDA 510(k)

CEREGLIDE 92导管系统

K号: K233982 · 2024-05-09

决定日期2024-05-09

产品代码QJP

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

CEREGLIDE 92 Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Cerenovus, Inc.. It received FDA 510(k) clearance on 2024-05-09 under 510(k) number K233982. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CEREGLIDE 92 Catheter System?

CEREGLIDE 92 Catheter System is a medical device that received FDA 510(k) clearance on 2024-05-09. The listed applicant is Cerenovus, Inc.. The 510(k) number is K233982.

When did CEREGLIDE 92 Catheter System receive FDA 510(k) clearance?

CEREGLIDE 92 Catheter System received FDA 510(k) clearance on 2024-05-09, under 510(k) number K233982.

Who is the listed applicant for CEREGLIDE 92 Catheter System?

FDA 510(k)记录中列出Cerenovus, Inc.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 CEREGLIDE 92 Catheter System?

The FDA product code for CEREGLIDE 92 Catheter System is QJP.

列明Cerenovus, Inc.为申报人的其他记录

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