雙通過雙通道導管
K 號：K193119 · 2020-06-29
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器材摘要
Twin-Pass Dual Access 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 2020-06-29 under 510(k) number K193119. 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 Twin-Pass Dual Access Catheter?
Twin-Pass Dual Access Catheter is a medical device that received FDA 510(k) clearance on 2020-06-29. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K193119.
When did Twin-Pass Dual Access Catheter receive FDA 510(k) clearance?
Twin-Pass Dual Access Catheter received FDA 510(k) clearance on 2020-06-29, under 510(k) number K193119.
Who is the listed applicant for Twin-Pass Dual Access 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 Twin-Pass Dual Access Catheter?
The FDA product code for Twin-Pass Dual Access Catheter is DQY.
相關臨床試驗
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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K212211Turnpike 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K212167R350導絲，Spectre導絲，Raider導絲，Bandit導絲，Warrior導絲
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。
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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