FDA 510(k)

NaviENT

K-Number: K163439 · 2017-09-01

Decision Date2017-09-01

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NaviENT is a medical device manufactured by Claronav, Inc.. It received FDA 510(k) clearance on 2017-09-01 under approval number K163439. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NaviENT?

NaviENT is a medical device that received FDA 510(k) clearance on 2017-09-01. It is manufactured by Claronav, Inc.. The 510(k) number is K163439.

When was NaviENT approved by the FDA?

NaviENT received FDA 510(k) clearance on 2017-09-01, under approval number K163439.

What company makes NaviENT?

NaviENT is manufactured by Claronav, Inc..

What is the FDA product code for NaviENT?

The FDA product code for NaviENT is HAW.

Other Devices by Claronav, Inc.

K161406Navident K210947Navident K233563Navident

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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.