Cleared Traditional

Esperance 3+ Aspiration Catheter System

K240917 · Wallaby Medical · Neurology

Oct 2024

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K240917 is an FDA 510(k) clearance for the Esperance 3+ Aspiration Catheter System, a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Wallaby Medical (Laguna Hills, US). The FDA issued a Cleared decision on October 1, 2024, 181 days after receiving the submission on April 3, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K240917 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2024
Decision Date	October 01, 2024
Days to Decision	181 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NRY — Catheter, Thrombus Retriever
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.