FDA 510(k)

无针经房间隔导管

K号: K172934 · 2018-02-16

申请人Pressure Products Medical Device Manufacturing, LLC

决定日期2018-02-16

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

Needle Free Transseptal Cannula 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 2018-02-16 under 510(k) number K172934. 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 Needle Free Transseptal Cannula?

Needle Free Transseptal Cannula is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K172934.

When did Needle Free Transseptal Cannula receive FDA 510(k) clearance?

Needle Free Transseptal Cannula received FDA 510(k) clearance on 2018-02-16, under 510(k) number K172934.

Who is the listed applicant for Needle Free Transseptal Cannula?

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 Needle Free Transseptal Cannula?

The FDA product code for Needle Free Transseptal Cannula is DRC.