Cleared Traditional

Wedge XL Delivery Catheter

K232542 · MicroVention, Inc. · Neurology

May 2024

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K232542 is an FDA 510(k) clearance for the Wedge XL Delivery Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by MicroVention, Inc. (Aliso Veijo, US). The FDA issued a Cleared decision on May 16, 2024, 268 days after receiving the submission on August 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K232542 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 2023
Decision Date	May 16, 2024
Days to Decision	268 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