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FDA 510(k)

Riptide Aspiration System (Riptide Large Bore Aspiration System)

K-Number: K183185 · 2018-12-18

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2018-12-18
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Riptide Aspiration System (Riptide Large Bore Aspiration System) is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2018-12-18 under approval number K183185. 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 Riptide Aspiration System (Riptide Large Bore Aspiration System)?

Riptide Aspiration System (Riptide Large Bore Aspiration System) is a medical device that received FDA 510(k) clearance on 2018-12-18. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K183185.

When was Riptide Aspiration System (Riptide Large Bore Aspiration System) approved by the FDA?

Riptide Aspiration System (Riptide Large Bore Aspiration System) received FDA 510(k) clearance on 2018-12-18, under approval number K183185.

What company makes Riptide Aspiration System (Riptide Large Bore Aspiration System)?

Riptide Aspiration System (Riptide Large Bore Aspiration System) is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

What is the FDA product code for Riptide Aspiration System (Riptide Large Bore Aspiration System)?

The FDA product code for Riptide Aspiration System (Riptide Large Bore Aspiration System) is NRY.

Related Clinical Trials

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

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Related Devices (Code: NRY)

K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular 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

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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