FDA 510(k)

NovaCross Microcatheter

K-Number: K160389 · 2016-03-11

Decision Date2016-03-11

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NovaCross Microcatheter is a medical device manufactured by Nitiloop , Ltd.. It received FDA 510(k) clearance on 2016-03-11 under approval number K160389. 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 NovaCross Microcatheter?

NovaCross Microcatheter is a medical device that received FDA 510(k) clearance on 2016-03-11. It is manufactured by Nitiloop , Ltd.. The 510(k) number is K160389.

When was NovaCross Microcatheter approved by the FDA?

NovaCross Microcatheter received FDA 510(k) clearance on 2016-03-11, under approval number K160389.

What company makes NovaCross Microcatheter?

NovaCross Microcatheter is manufactured by Nitiloop , Ltd..

What is the FDA product code for NovaCross Microcatheter?

The FDA product code for NovaCross Microcatheter is DQY.

Other Devices by Nitiloop , Ltd.

K172297NovaCross Microcatheter K193322NovaCross CTO Microcatheter

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, Inc.

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.