FDA 510(k)

双腔输尿管通道导管，Flexi-Tip双腔输尿管通道导管

K号: K180182 · 2018-09-14

决定日期2018-09-14

产品代码EYB

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决定实质等同

器械摘要

Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K180182. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter?

Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Cook Incorporated. The 510(k) number is K180182.

When did Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter receive FDA 510(k) clearance?

Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter received FDA 510(k) clearance on 2018-09-14, under 510(k) number K180182.

Who is the listed applicant for Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter?

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

What is the FDA product code for Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter?

The FDA product code for Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter is EYB.

列明Cook Incorporated为申报人的其他记录

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