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FDA 510(k)

Riptide Aspiration System

K-Number: K201689 · 2020-07-21

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2020-07-21
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Riptide Aspiration System is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2020-07-21 under approval number K201689. 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 Aspiration System is a medical device that received FDA 510(k) clearance on 2020-07-21. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K201689.

When was Riptide Aspiration System approved by the FDA?

Riptide Aspiration System received FDA 510(k) clearance on 2020-07-21, under approval number K201689.

What company makes Riptide Aspiration System?

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

What is the FDA product code for Riptide Aspiration System?

The FDA product code for Riptide Aspiration System is NRY.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING

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

K162539Solitaire 2 Revascularization Device 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

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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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