Cleared Traditional

Esperance Aspiration Catheter System

K211697 · Wallaby Medical · Neurology

Nov 2021

Decision

166d

Days

Class 2

Risk

About This 510(k) Submission

K211697 is an FDA 510(k) clearance for the Esperance 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 November 16, 2021, 166 days after receiving the submission on June 3, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K211697 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2021
Decision Date	November 16, 2021
Days to Decision	166 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.