FDA 510(k)

Drakon 及 Sequre 微导管

K 號：K202797 · 2020-10-23

決定日期2020-10-23

產品代碼DQO

諮詢委員會履歷

決定相當於

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, Ltd.. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K202797. 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 2020-10-23. The listed applicant is Accurate Medical Therapeutics, Ltd.. The 510(k) number is K202797.

When did Drakon and Sequre Microcatheters receive FDA 510(k) clearance?

Drakon and Sequre Microcatheters received FDA 510(k) clearance on 2020-10-23, under 510(k) number K202797.

Who is the listed applicant for Drakon 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 Drakon and Sequre Microcatheters?

The FDA product code for Drakon 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 K173430SeQure® NF 和 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.

官方來源

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