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FDA 510(k)

NaviCross 0.018

K-Number: K173799 · 2018-03-29

ApplicantTerumo Corporation
Decision Date2018-03-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NaviCross 0.018 is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2018-03-29 under 510(k) number K173799. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NaviCross 0.018?

NaviCross 0.018 is a medical device that received FDA 510(k) clearance on 2018-03-29. The listed applicant is Terumo Corporation. The 510(k) number is K173799.

When did NaviCross 0.018 receive FDA 510(k) clearance?

NaviCross 0.018 received FDA 510(k) clearance on 2018-03-29, under 510(k) number K173799.

Who is the listed applicant for NaviCross 0.018?

The FDA 510(k) record lists Terumo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NaviCross 0.018?

The FDA product code for NaviCross 0.018 is DQY.

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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.

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