Cleared Traditional

Access25? Delivery Microcatheter

K242033 · Penumbra, Inc. · Neurology

Dec 2024

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K242033 is an FDA 510(k) clearance for the Access25? Delivery Microcatheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on December 11, 2024, 153 days after receiving the submission on July 11, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K242033 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2024
Decision Date	December 11, 2024
Days to Decision	153 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