FDA 510(k)

Python 导管/导丝 Latis 移植物清洁导管

K号: K202049 · 2021-09-07

申请人Applied Medical Resources Corporation

决定日期2021-09-07

产品代码DXE

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

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2021-09-07 under 510(k) number K202049. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter?

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter is a medical device that received FDA 510(k) clearance on 2021-09-07. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K202049.

When did Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter receive FDA 510(k) clearance?

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter received FDA 510(k) clearance on 2021-09-07, under 510(k) number K202049.

Who is the listed applicant for Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter?

The FDA product code for Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter is DXE.

列明Applied Medical Resources Corporation为申报人的其他记录

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