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FDA 510(k)

Cleveland 多端口腦室導管套組

K 號:K161731 · 2017-03-27

決定日期2017-03-27
產品代碼HCA
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

Cleveland Multiport Ventricular Catheter Set is the device name listed in this FDA 510(k) record. The listed applicant is Parker Hannifin Corp.. It received FDA 510(k) clearance on 2017-03-27 under 510(k) number K161731. The device is classified under product code HCA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cleveland Multiport Ventricular Catheter Set?

Cleveland Multiport Ventricular Catheter Set is a medical device that received FDA 510(k) clearance on 2017-03-27. The listed applicant is Parker Hannifin Corp.. The 510(k) number is K161731.

When did Cleveland Multiport Ventricular Catheter Set receive FDA 510(k) clearance?

Cleveland Multiport Ventricular Catheter Set received FDA 510(k) clearance on 2017-03-27, under 510(k) number K161731.

Who is the listed applicant for Cleveland Multiport Ventricular Catheter Set?

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

What is the FDA product code for Cleveland Multiport Ventricular Catheter Set?

The FDA product code for Cleveland Multiport Ventricular Catheter Set is HCA.

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