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FDA 510(k)

Navien Intracranial Support Catheter

K-Number: K161152 · 2016-10-12

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2016-10-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Navien Intracranial Support Catheter is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2016-10-12 under approval number K161152. 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 Navien Intracranial Support Catheter?

Navien Intracranial Support Catheter is a medical device that received FDA 510(k) clearance on 2016-10-12. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K161152.

When was Navien Intracranial Support Catheter approved by the FDA?

Navien Intracranial Support Catheter received FDA 510(k) clearance on 2016-10-12, under approval number K161152.

What company makes Navien Intracranial Support Catheter?

Navien Intracranial Support Catheter is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

What is the FDA product code for Navien Intracranial Support Catheter?

The FDA product code for Navien Intracranial Support Catheter 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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