FDA 510(k)

SeQure® NF 和 SeQure® 微导管

K 號：K173430 · 2018-01-26

決定日期2018-01-26

產品代碼DQO

諮詢委員會履歷

決定相當於

器材摘要

SeQure® NF and SeQure® Microcatheters is the device name listed in this FDA 510(k) record. The listed applicant is Accurate Medical Therapeutics, Ltd.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K173430. 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 SeQure® NF and SeQure® Microcatheters?

SeQure® NF and SeQure® Microcatheters is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Accurate Medical Therapeutics, Ltd.. The 510(k) number is K173430.

When did SeQure® NF and SeQure® Microcatheters receive FDA 510(k) clearance?

SeQure® NF and SeQure® Microcatheters received FDA 510(k) clearance on 2018-01-26, under 510(k) number K173430.

Who is the listed applicant for SeQure® NF and SeQure® Microcatheters?

The FDA 510(k) record lists Accurate Medical Therapeutics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SeQure® NF and SeQure® Microcatheters?

The FDA product code for SeQure® NF and SeQure® Microcatheters is DQO.

其他以 Accurate Medical Therapeutics, Ltd. 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。

K203487Drakon 及 Sequre 微导管 K202797Drakon 及 Sequre 微导管

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 Vascular K252702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 Vascular K250751雙視窗導管Terumo Corporation K242966Gentuity® 高頻率OCT影像系統搭配Vis-Rx Prime® 微影像導管Gentuity, LLC K242420pNOVUS 21 微导管Phenox, Ltd.

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