Cleared Traditional

Esperance Distal Access Catheter

K231056 · Wallaby Medical · Neurology

Mar 2024

Decision

330d

Days

Class 2

Risk

About This 510(k) Submission

K231056 is an FDA 510(k) clearance for the Esperance Distal Access Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Wallaby Medical (Laguna Hills, US). The FDA issued a Cleared decision on March 8, 2024, 330 days after receiving the submission on April 13, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K231056 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2023
Decision Date	March 08, 2024
Days to Decision	330 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QJP — Catheter, Percutaneous, Neurovasculature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures