FDA 510(k)

Dornier MINNOW 肾盂输尿管导管

K号: K191187 · 2019-09-18

决定日期2019-09-18

产品代码EYB

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决定实质等同

器械摘要

Dornier MINNOW Ureteral Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2019-09-18 under 510(k) number K191187. 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 Dornier MINNOW Ureteral Catheter?

Dornier MINNOW Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K191187.

When did Dornier MINNOW Ureteral Catheter receive FDA 510(k) clearance?

Dornier MINNOW Ureteral Catheter received FDA 510(k) clearance on 2019-09-18, under 510(k) number K191187.

Who is the listed applicant for Dornier MINNOW Ureteral Catheter?

The FDA 510(k) record lists Dornier Medtech America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dornier MINNOW Ureteral Catheter?

The FDA product code for Dornier MINNOW Ureteral Catheter is EYB.

列明Dornier Medtech America, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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