FDA 510(k)

FlexCath Advance可弯曲鞘和扩张器

K号: K183174 · 2018-11-26

决定日期2018-11-26

产品代码DRA

咨询委员会CV

决定Substantially Equivalent

器械摘要

FlexCath Advance Steerable Sheath and Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Cryocath, LP. It received FDA 510(k) clearance on 2018-11-26 under 510(k) number K183174. 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 FlexCath Advance Steerable Sheath and Dilator?

FlexCath Advance Steerable Sheath and Dilator is a medical device that received FDA 510(k) clearance on 2018-11-26. The listed applicant is Medtronic Cryocath, LP. The 510(k) number is K183174.

When did FlexCath Advance Steerable Sheath and Dilator receive FDA 510(k) clearance?

FlexCath Advance Steerable Sheath and Dilator received FDA 510(k) clearance on 2018-11-26, under 510(k) number K183174.

Who is the listed applicant for FlexCath Advance Steerable Sheath and Dilator?

The FDA 510(k) record lists Medtronic Cryocath, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlexCath Advance Steerable Sheath and Dilator?

The FDA product code for FlexCath Advance Steerable Sheath and Dilator is DRA.

列明Medtronic Cryocath, LP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。

K202620FlexCath Advance可弯曲鞘和扩张器 K163268FlexCath Select 可弯曲导管鞘和扩张器

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™ Steerable Sheath (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

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