FDA 510(k)

AMPLATZER TorqVue 45x45 递送鞘

K号: K163000 · 2016-12-23

申请人Aga Medical COrporation (Wholly Owned by St. Jude Medical CO

决定日期2016-12-23

产品代码DQY

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

AMPLATZER TorqVue 45x45 Delivery Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K163000. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AMPLATZER TorqVue 45x45 Delivery Sheath?

AMPLATZER TorqVue 45x45 Delivery Sheath is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. The 510(k) number is K163000.

When did AMPLATZER TorqVue 45x45 Delivery Sheath receive FDA 510(k) clearance?

AMPLATZER TorqVue 45x45 Delivery Sheath received FDA 510(k) clearance on 2016-12-23, under 510(k) number K163000.

Who is the listed applicant for AMPLATZER TorqVue 45x45 Delivery Sheath?

The FDA 510(k) record lists Aga Medical COrporation (Wholly Owned by St. Jude Medical CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMPLATZER TorqVue 45x45 Delivery Sheath?

The FDA product code for AMPLATZER TorqVue 45x45 Delivery Sheath is DQY.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

AMPLATZER TorqVue 45x45 递送鞘

器械摘要

常见问题

相关临床试验

相关器械（代码：DQY）

官方来源