Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ClariVein IC

K-Number: K153502 · 2016-01-06

Decision Date2016-01-06
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ClariVein IC is a medical device manufactured by Vascular Insights, LLC. It received FDA 510(k) clearance on 2016-01-06 under approval number K153502. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClariVein IC?

ClariVein IC is a medical device that received FDA 510(k) clearance on 2016-01-06. It is manufactured by Vascular Insights, LLC. The 510(k) number is K153502.

When was ClariVein IC approved by the FDA?

ClariVein IC received FDA 510(k) clearance on 2016-01-06, under approval number K153502.

What company makes ClariVein IC?

ClariVein IC is manufactured by Vascular Insights, LLC.

What is the FDA product code for ClariVein IC?

The FDA product code for ClariVein IC is KRA.

Related Devices (Code: KRA)

Official Source

View on FDA Database →

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