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FDA 510(k)

Solitaire 2 Revascularization Device

K-Number: K162539 · 2016-11-10

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2016-11-10
Product CodePOL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Solitaire 2 Revascularization Device is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2016-11-10 under approval number K162539. The device is classified under product code POL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solitaire 2 Revascularization Device?

Solitaire 2 Revascularization Device is a medical device that received FDA 510(k) clearance on 2016-11-10. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K162539.

When was Solitaire 2 Revascularization Device approved by the FDA?

Solitaire 2 Revascularization Device received FDA 510(k) clearance on 2016-11-10, under approval number K162539.

What company makes Solitaire 2 Revascularization Device?

Solitaire 2 Revascularization Device is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

What is the FDA product code for Solitaire 2 Revascularization Device?

The FDA product code for Solitaire 2 Revascularization Device is POL.

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Other Devices by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K161152Navien Intracranial Support Catheter K161879Solitaire Platinum Revascularization Device K172448Riptide Aspiration System K171268Reverse 021 Micro Catheter, Reverse 027 Micro Catheter K160641Solitaire Platinum Revascularization Device, 6x40 mm K162704Axium Prime Detachable Coil System

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Related Devices (Code: POL)

DEN150049Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mmConcentric Medical, Inc. K181186Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K181060Solitaire 2 and Solitaire Platinum Revascularization DeviceMedtronic Neurovascular K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)Concentric Medical, Inc. K192207Trevo NXT ProVue RetrieverStryker K190779Trevo XP ProVue RetrieverStryker

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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