FDA 510(k)

Voyager 轨迹阵列指南（V-TAG）

K号: K191400 · 2019-06-21

决定日期2019-06-21

产品代码HAW

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决定实质等同

器械摘要

Voyager Trajectory Array Guide (V-TAG) is the device name listed in this FDA 510(k) record. The listed applicant is Mri Interventions, Inc.. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K191400. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Voyager Trajectory Array Guide (V-TAG)?

Voyager Trajectory Array Guide (V-TAG) is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K191400.

When did Voyager Trajectory Array Guide (V-TAG) receive FDA 510(k) clearance?

Voyager Trajectory Array Guide (V-TAG) received FDA 510(k) clearance on 2019-06-21, under 510(k) number K191400.

Who is the listed applicant for Voyager Trajectory Array Guide (V-TAG)?

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

What is the FDA product code for Voyager Trajectory Array Guide (V-TAG)?

The FDA product code for Voyager Trajectory Array Guide (V-TAG) is HAW.

列明Mri Interventions, Inc.为申报人的其他记录

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