Cleared Traditional

Esperance Distal Access Catheter (K231056) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231056 · Wallaby Medical · Neurology device
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Mar 2024
Decision
330d
Days
Class 2
Risk

K231056 is an FDA 510(k) clearance for the Esperance Distal Access Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Wallaby Medical (Laguna Hills, US). The FDA issued a Cleared decision on March 8, 2024 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wallaby Medical devices

Submission Details

510(k) Number K231056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 148d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - QJP Catheter, Percutaneous, Neurovasculature

All 90
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K231056.
CEREGLIDE 92 Catheter System
K233982 · Cerenovus, Inc. · May 2024
EMBOGUARD Balloon Guide Catheter
K233924 · Neuravi Limited · Apr 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
K233201 · Penumbra, Inc. · Mar 2024
Distal Access Catheter
K231218 · Accumedical Beijing , Ltd. · Jan 2024
Distal Access Catheter
K233205 · Shanghai Heartcare Medical Technology Co., Ltd. · Dec 2023
Millipede 088 Access Catheter
K233648 · Perfuze, Ltd. · Dec 2023