FDA 510(k)

SafeSept 经隔膜导丝

K号: K170671 · 2017-10-20

申请人Pressure Products Medical Device Manufacturing, LLC

决定日期2017-10-20

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 Transseptal Guidewire 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 2017-10-20 under 510(k) number K170671. 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 Transseptal Guidewire?

SafeSept Transseptal Guidewire is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K170671.

When did SafeSept Transseptal Guidewire receive FDA 510(k) clearance?

SafeSept Transseptal Guidewire received FDA 510(k) clearance on 2017-10-20, under 510(k) number K170671.

Who is the listed applicant for SafeSept Transseptal Guidewire?

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 Transseptal Guidewire?

The FDA product code for SafeSept Transseptal Guidewire is DRC.