FDA 510(k)

Dornier MAGELLAN 肾盂输尿管支架

K号: K201815 · 2020-11-20

决定日期2020-11-20

产品代码FED

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决定实质等同

器械摘要

Dornier MAGELLAN Ureteral Access Sheath 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 2020-11-20 under 510(k) number K201815. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dornier MAGELLAN Ureteral Access Sheath?

Dornier MAGELLAN Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K201815.

When did Dornier MAGELLAN Ureteral Access Sheath receive FDA 510(k) clearance?

Dornier MAGELLAN Ureteral Access Sheath received FDA 510(k) clearance on 2020-11-20, under 510(k) number K201815.

Who is the listed applicant for Dornier MAGELLAN Ureteral Access Sheath?

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 MAGELLAN Ureteral Access Sheath?

The FDA product code for Dornier MAGELLAN Ureteral Access Sheath is FED.

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

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