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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 the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2016-10-12 under 510(k) 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. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K161152.

When did Navien Intracranial Support Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Navien Intracranial Support Catheter?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Navien Intracranial Support Catheter is DQY.

Other records listing Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as applicant

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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