FDA 510(k)

DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak

K 號：K161287 · 2016-08-19

決定日期2016-08-19

產品代碼DQO

諮詢委員會履歷

決定Unknown

器材摘要

DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K161287. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常見問題

What is the DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak?

DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Medtronic Vascular. The 510(k) number is K161287.

When did DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak receive FDA 510(k) clearance?

DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak received FDA 510(k) clearance on 2016-08-19, under 510(k) number K161287.

Who is the listed applicant for DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak?

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

What is the FDA product code for DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak?

The FDA product code for DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak is DQO.

其他以 Medtronic Vascular 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。

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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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