FDA 510(k)

FlexCath Select 可弯曲导管鞘和扩张器

K号: K163268 · 2017-02-02

决定日期2017-02-02

产品代码DYB

咨询委员会CV

决定Substantially Equivalent

器械摘要

FlexCath Select Steerable Shealth 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 2017-02-02 under 510(k) number K163268. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FlexCath Select Steerable Shealth and Dilator?

FlexCath Select Steerable Shealth and Dilator is a medical device that received FDA 510(k) clearance on 2017-02-02. The listed applicant is Medtronic Cryocath, LP. The 510(k) number is K163268.

When did FlexCath Select Steerable Shealth and Dilator receive FDA 510(k) clearance?

FlexCath Select Steerable Shealth and Dilator received FDA 510(k) clearance on 2017-02-02, under 510(k) number K163268.

Who is the listed applicant for FlexCath Select Steerable Shealth 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 Select Steerable Shealth and Dilator?

The FDA product code for FlexCath Select Steerable Shealth and Dilator is DYB.

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 K183174FlexCath Advance可弯曲鞘和扩张器

相关器械（代码：DYB）

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。

K253526NAMIC Dilator and SheathMedline Industries, LP K261529微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（SIS05C）；微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（IS01）；引导器套件/微引导器套件/引导器套装/微引导器套装/微引导器鞘套装/引导器鞘套装（NIS04）Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line 可撕开引导器Health Line International Corporation K261492FieldFlex 可弯曲鞘CenterPoint Systems, LLC K260606Echo 大口径引导鞘Echo Medical, LLC

官方来源

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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。