FDA 510(k)

一次性无菌高压造影注射器及附件

K号: K241109 · 2024-08-22

申请人Shenzhen Boon Medical Supply Co., Ltd.

决定日期2024-08-22

产品代码DXT

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

Single-use Sterile High-pressure Angiographic Syringes and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Boon Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K241109. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Single-use Sterile High-pressure Angiographic Syringes and Accessories?

Single-use Sterile High-pressure Angiographic Syringes and Accessories is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Shenzhen Boon Medical Supply Co., Ltd.. The 510(k) number is K241109.

When did Single-use Sterile High-pressure Angiographic Syringes and Accessories receive FDA 510(k) clearance?

Single-use Sterile High-pressure Angiographic Syringes and Accessories received FDA 510(k) clearance on 2024-08-22, under 510(k) number K241109.

Who is the listed applicant for Single-use Sterile High-pressure Angiographic Syringes and Accessories?

The FDA 510(k) record lists Shenzhen Boon Medical Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use Sterile High-pressure Angiographic Syringes and Accessories?

The FDA product code for Single-use Sterile High-pressure Angiographic Syringes and Accessories is DXT.

列明Shenzhen Boon Medical Supply Co., Ltd.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。

K211564无菌一次性使用高压造影注射器 K192657无菌一次性使用高压造影注射器

相关器械（代码：DXT）

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

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