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FDA 510(k)

Esperance 3+ Aspiration Catheter System

K-Number: K240917 · 2024-10-01

ApplicantWallaby Medical
Decision Date2024-10-01
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Esperance 3+ Aspiration Catheter System is a medical device manufactured by Wallaby Medical. It received FDA 510(k) clearance on 2024-10-01 under approval number K240917. 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 Esperance 3+ Aspiration Catheter System?

Esperance 3+ Aspiration Catheter System is a medical device that received FDA 510(k) clearance on 2024-10-01. It is manufactured by Wallaby Medical. The 510(k) number is K240917.

When was Esperance 3+ Aspiration Catheter System approved by the FDA?

Esperance 3+ Aspiration Catheter System received FDA 510(k) clearance on 2024-10-01, under approval number K240917.

What company makes Esperance 3+ Aspiration Catheter System?

Esperance 3+ Aspiration Catheter System is manufactured by Wallaby Medical.

What is the FDA product code for Esperance 3+ Aspiration Catheter System?

The FDA product code for Esperance 3+ Aspiration Catheter System 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 Wallaby Medical

K211697Esperance Aspiration Catheter System K232437Paragon 8F Balloon Guide Catheter K223139Wallaby 017 Micro Catheter K231056Esperance Distal Access Catheter

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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