FDA 510(k)

Gentuity® 高頻率OCT影像系統搭配Vis-Rx® 微影像導管

K 號：K230620 · 2023-08-08

決定日期2023-08-08

產品代碼DQO

諮詢委員會履歷

決定相當於

器材摘要

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Gentuity, LLC. It received FDA 510(k) clearance on 2023-08-08 under 510(k) number K230620. 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 Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter?

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is a medical device that received FDA 510(k) clearance on 2023-08-08. The listed applicant is Gentuity, LLC. The 510(k) number is K230620.

When did Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter receive FDA 510(k) clearance?

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter received FDA 510(k) clearance on 2023-08-08, under 510(k) number K230620.

Who is the listed applicant for Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter?

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

What is the FDA product code for Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter?

The FDA product code for Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is DQO.

其他以 Gentuity, 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。

K242966Gentuity® 高頻率OCT影像系統搭配Vis-Rx Prime® 微影像導管 K242239HF-OCT影像系統搭配Vis-RX微影像導管（G10（HF-OCT控制台），G30（Vis-Rx微影像導管））K192922Gentuity HF-OCT影像系統搭配Vis-Rx微影像導管

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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