FDA 510(k)

Hansen Medical Magellan 机器人导管 eKit

K号: K153304 · 2016-02-01

决定日期2016-02-01

产品代码DRA

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

Hansen Medical Magellan Robotic Catheter eKit is the device name listed in this FDA 510(k) record. The listed applicant is Hansen Medical, Inc.. It received FDA 510(k) clearance on 2016-02-01 under 510(k) number K153304. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hansen Medical Magellan Robotic Catheter eKit?

Hansen Medical Magellan Robotic Catheter eKit is a medical device that received FDA 510(k) clearance on 2016-02-01. The listed applicant is Hansen Medical, Inc.. The 510(k) number is K153304.

When did Hansen Medical Magellan Robotic Catheter eKit receive FDA 510(k) clearance?

Hansen Medical Magellan Robotic Catheter eKit received FDA 510(k) clearance on 2016-02-01, under 510(k) number K153304.

Who is the listed applicant for Hansen Medical Magellan Robotic Catheter eKit?

The FDA 510(k) record lists Hansen Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hansen Medical Magellan Robotic Catheter eKit?

The FDA product code for Hansen Medical Magellan Robotic Catheter eKit is DRA.

列明Hansen Medical, Inc.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。

K160919Hansen Medical Magellan 9Fr 机器人导管

相关器械（代码：DRA）

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。

K262165FARADRIVE™ 导向鞘（M004PF21M402）Boston Scientific Corporation K250529Globe Introducer (601-01001)Kardium, Inc.K233248FARADRIVE™ 可弯曲鞘Boston Scientific Corporation K232321FlexCath Contour™ 可弯曲导管鞘Medtronic, Inc.K223824POLARSHEATH™ 可弯曲鞘 12F（UPN:M004CRBS3150），POLARMAP™ 圆形测绘导管（UPN:M004CRBS7210），POLARMAP™ EP 电缆（UPN:M004CRBS62000），SMARTFREEZE™ 食管温度传感器（ETS）电缆：-SMARTFREEZE™ 食管温度传感器（ETS）电缆（UPN: M004CRBS6310），-SMARTFREEZE™ 16 PIN 食管温度传感器（ETS）电缆（UPN: M004CRBS6320），-SMARTFREEZE™ CIRCA 食管温度传感器（ETS）电缆（UPN: M004CRBS6340），SMARTFREEZE™ 压力传感器Boston Scientific Corporation K221397MitraClip G4 可控导引导管ABBOTT MEDICAL

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。