FDA 510(k)

无菌一次性使用高压造影注射器

K号: K151960 · 2016-01-07

申请人Shenzhen Baoan Medical Supplies Co., Ltd.

决定日期2016-01-07

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

Sterile High-pressure Angiographic Syringes for Single-use is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Baoan Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K151960. 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 Sterile High-pressure Angiographic Syringes for Single-use?

Sterile High-pressure Angiographic Syringes for Single-use is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Shenzhen Baoan Medical Supplies Co., Ltd.. The 510(k) number is K151960.

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

Sterile High-pressure Angiographic Syringes for Single-use received FDA 510(k) clearance on 2016-01-07, under 510(k) number K151960.

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

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

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

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

列明Shenzhen Baoan Medical Supplies 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。

K182289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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