FDA 510(k)

OptiCross 18, 30 MHz 頻外影像導管

K 號：K160514 · 2016-06-22

決定日期2016-06-22

產品代碼OBJ

諮詢委員會履歷

決定相當於

器材摘要

OptiCross 18, 30 MHz Peripheral Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-06-22 under 510(k) number K160514. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OptiCross 18, 30 MHz Peripheral Imaging Catheter?

OptiCross 18, 30 MHz Peripheral Imaging Catheter is a medical device that received FDA 510(k) clearance on 2016-06-22. The listed applicant is Boston Scientific Corporation. The 510(k) number is K160514.

When did OptiCross 18, 30 MHz Peripheral Imaging Catheter receive FDA 510(k) clearance?

OptiCross 18, 30 MHz Peripheral Imaging Catheter received FDA 510(k) clearance on 2016-06-22, under 510(k) number K160514.

Who is the listed applicant for OptiCross 18, 30 MHz Peripheral Imaging Catheter?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for OptiCross 18, 30 MHz Peripheral Imaging Catheter?

The FDA product code for OptiCross 18, 30 MHz Peripheral Imaging Catheter is OBJ.

其他以 Boston Scientific Corporation 為申請人之記錄

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相關器械（代碼：OBJ）

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