FDA 510(k)

SafeSept 钝头针

K号: K210328 · 2021-03-05

申请人Pressure Products Medical Device Manufacturing, LLC

决定日期2021-03-05

产品代码DRC

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

SafeSept Blunt Needle is the device name listed in this FDA 510(k) record. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K210328. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SafeSept Blunt Needle?

SafeSept Blunt Needle is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K210328.

When did SafeSept Blunt Needle receive FDA 510(k) clearance?

SafeSept Blunt Needle received FDA 510(k) clearance on 2021-03-05, under 510(k) number K210328.

Who is the listed applicant for SafeSept Blunt Needle?

The FDA 510(k) record lists Pressure Products Medical Device Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeSept Blunt Needle?

The FDA product code for SafeSept Blunt Needle is DRC.