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FDA 510(k)

Verza Guidance System

K-Number: K160806 · 2016-08-05

Decision Date2016-08-05
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Verza Guidance System is a medical device manufactured by CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 2016-08-05 under approval number K160806. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Verza Guidance System?

Verza Guidance System is a medical device that received FDA 510(k) clearance on 2016-08-05. It is manufactured by CIVCO Medical Instruments Co., Inc.. The 510(k) number is K160806.

When was Verza Guidance System approved by the FDA?

Verza Guidance System received FDA 510(k) clearance on 2016-08-05, under approval number K160806.

What company makes Verza Guidance System?

Verza Guidance System is manufactured by CIVCO Medical Instruments Co., Inc..

What is the FDA product code for Verza Guidance System?

The FDA product code for Verza Guidance System is ITX.

Related Clinical Trials

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Other Devices by CIVCO Medical Instruments Co., Inc.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.