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FDA 510(k)

Solitaire Platinum Revascularization Device

K-Number: K161879 · 2016-09-21

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2016-09-21
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Solitaire Platinum Revascularization Device is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2016-09-21 under approval number K161879. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solitaire Platinum Revascularization Device?

Solitaire Platinum Revascularization Device is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K161879.

When was Solitaire Platinum Revascularization Device approved by the FDA?

Solitaire Platinum Revascularization Device received FDA 510(k) clearance on 2016-09-21, under approval number K161879.

What company makes Solitaire Platinum Revascularization Device?

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

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

The FDA product code for Solitaire Platinum Revascularization Device is NRY.

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

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Related Devices (Code: NRY)

K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162901Penumbra 3D Revascularization DevicePenumbra, Inc.

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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