FDA 510(k)

TightRail 子型旋轉擴張鞘

K 號：K161333 · 2016-07-08

決定日期2016-07-08

產品代碼DRE

諮詢委員會履歷

決定相當於

器材摘要

TightRail Sub-C Rotating Dilator Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics, Inc.. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K161333. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TightRail Sub-C Rotating Dilator Sheath?

TightRail Sub-C Rotating Dilator Sheath is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Spectranetics, Inc.. The 510(k) number is K161333.

When did TightRail Sub-C Rotating Dilator Sheath receive FDA 510(k) clearance?

TightRail Sub-C Rotating Dilator Sheath received FDA 510(k) clearance on 2016-07-08, under 510(k) number K161333.

Who is the listed applicant for TightRail Sub-C Rotating Dilator Sheath?

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

What is the FDA product code for TightRail Sub-C Rotating Dilator Sheath?

The FDA product code for TightRail Sub-C Rotating Dilator Sheath is DRE.

其他以 Spectranetics, Inc. 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。

K223472TightRail 監護動力擴張鞘，9 法寸（575-009）；TightRail 監護動力擴張鞘，11 法寸（575-011）；TightRail 監護動力擴張鞘，13 法寸（575-013）K222837超功率（2.0mm）雷射動脈內切除針，超功率（2.3mm）雷射動脈內切除針 K212784TightRail 監護動力擴張鞘 K203540橋接閉塞球 K180694超功率（2.0mm）雷射動脈內切除針，超功率（2.3mm）雷射動脈內切除針 K172687超功率（2.0mm）雷射動脈內切除針，超功率（2.3mm）雷射動脈內切除針

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相關器械（代碼：DRE）

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。

K261310FlexTract 可調向旋轉擴張針鞘組Merit Medical Systems, Inc.K253616ProtekDilate 血管通路套件Sorin Group Italia S.R.L.K251325VersaCross Connect™ 開窗擴張器Baylis Medical Company, Inc.K242229微針金進階微針接入系統Merit Medical Systems, Inc.K241720VersaCross Connect™ 開窗擴張器Baylis Medical Company, Inc.K233647VersaCross Connect™ 開窗擴張器Baylis Medical Company, Inc.

官方來源

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