Drakon™ 及 Sequre® 微导管
K 號：K231293 · 2023-06-01
廣告
器材摘要
Drakon™ and Sequre® Microcatheters is the device name listed in this FDA 510(k) record. The listed applicant is Accurate Medical Therapeutics. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K231293. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Drakon™ and Sequre® Microcatheters?
Drakon™ and Sequre® Microcatheters is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Accurate Medical Therapeutics. The 510(k) number is K231293.
When did Drakon™ and Sequre® Microcatheters receive FDA 510(k) clearance?
Drakon™ and Sequre® Microcatheters received FDA 510(k) clearance on 2023-06-01, under 510(k) number K231293.
Who is the listed applicant for Drakon™ and Sequre® Microcatheters?
The FDA 510(k) record lists Accurate Medical Therapeutics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Drakon™ and Sequre® Microcatheters?
The FDA product code for Drakon™ and Sequre® Microcatheters is DQO.
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。
相關器械（代碼：DQO）
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。
K261455動脈壓力監測組/托盤Spectrum VascularK252702生物優質肺動脈監測導管（TD2502NF、TD2502NGF、TD2502NDF、TD2502NCF、TD2502NCGF、TD2502NDGF、TD2502NDCF、TD2502NDCGF、TD2502NXCF、TD2502NDXF、TD2502NXCGF、TD2502NDXGF、TD2502NDXCF、TD2502NDXCGF、TD2502-110NF、TD2502-110NGF、TD2502-110NDF、TD2502-110NCF、TD2502-110NDGF、TD2502-110NDCF、TD2502-110NCGF、TD2502-110NDCGF、TD2502-110NXF、TD2502-110NXGF、TD2502-110NDXF、TD2502-110NXCF、TD2502-110NDXGF、TD2502-110NDXCF，TD2502-110NXCGF，TD2502-110NDXCGF，TD2602NF，TD2602N）Bioptimal International Pte. , Ltd.K254278動脈壓力監測組/托盤Spectrum VascularK250751雙視窗導管Terumo CorporationK242966Gentuity® 高頻率OCT影像系統搭配Vis-Rx Prime® 微影像導管Gentuity, LLCK242420pNOVUS 21 微导管Phenox, Ltd.
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。
廣告