Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Riptide Aspiration System (React 71 Catheter)

K-Number: K182101 · 2018-11-14

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2018-11-14
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Riptide Aspiration System (React 71 Catheter) is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2018-11-14 under approval number K182101. 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 (React 71 Catheter)?

Riptide Aspiration System (React 71 Catheter) is a medical device that received FDA 510(k) clearance on 2018-11-14. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K182101.

When was Riptide Aspiration System (React 71 Catheter) approved by the FDA?

Riptide Aspiration System (React 71 Catheter) received FDA 510(k) clearance on 2018-11-14, under approval number K182101.

What company makes Riptide Aspiration System (React 71 Catheter)?

Riptide Aspiration System (React 71 Catheter) is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

What is the FDA product code for Riptide Aspiration System (React 71 Catheter)?

The FDA product code for Riptide Aspiration System (React 71 Catheter) is NRY.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) 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

View all 28 devices →

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.

↑