FDA 510(k)

FlexCath Select Steerable Shealth and Dilator

K 號：K163268 · 2017-02-02

決定日期2017-02-02

產品代碼DYB

諮詢委員會CV

決定Substantially Equivalent

器材摘要

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.

常見問題

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.

其他以 Medtronic Cryocath, LP 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：DYB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

官方來源

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