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FDA 510(k)

Turnpike 球囊導管，Turnpike 螺旋球囊導管，Turnpike LP 球囊導管，Turnpike 金導管，GuideLiner V3 球囊導管，TrapLiner 球囊導管

K 號：K212211 · 2022-02-09

申請人Vascular Solutions, LLC
決定日期2022-02-09
產品代碼DQY
諮詢委員會履歷
決定相當於

器材摘要

Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, LLC. It received FDA 510(k) clearance on 2022-02-09 under 510(k) number K212211. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter?

Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter is a medical device that received FDA 510(k) clearance on 2022-02-09. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K212211.

When did Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter receive FDA 510(k) clearance?

Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter received FDA 510(k) clearance on 2022-02-09, under 510(k) number K212211.

Who is the listed applicant for Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter?

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

What is the FDA product code for Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter?

The FDA product code for Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter is DQY.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Vascular Solutions, LLC 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。

K233729林格灌注球囊心导管，2.00 x 20mm（5881）；林格灌注球囊心导管，2.50 x 20mm（5882）；林格灌注球囊心导管，2.50 x 30mm（5883）；林格灌注球囊心导管，3.00 x 20mm（5884）；林格灌注球囊心导管，3.00 x 30mm（5885）；林格灌注球囊心导管，3.50 x 20mm（5886）；林格灌注球囊心导管，3.50 x 30mm（5887）；林格灌注球囊心导管，4.00 x 20mm（5888）；林格灌注球囊心导管，4.00 x 30mm（5889）K230637Wattson臨時起搏導絲（2250）K220647GuideLiner Coast, 5.5F (5270)；GuideLiner Coast，6F（5271）；GuideLiner Coast，7F（5272）；GuideLiner Coast，8F（5273）K221470Langston雙腔導管K212167R350導絲，Spectre導絲，Raider導絲，Bandit導絲，Warrior導絲K210647SuperCross 微导管，SuperCross FT 微导管，SuperCross AT 微导管

查看所有 11 項裝置 →

相關器械（代碼：DQY）

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。

K262817CrossFAST整合式微导管先進輸送系統Vantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift 管針Alembic, LLCK262240SSPC NXT 輸送導管CenterPoint Systems, LLCK261766CPS 定位器 3D Plus 輸送导管CenterPoint Systems, LLCK261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管Abbott

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

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