Cleared Traditional

MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)

K233201 · Penumbra, Inc. · Neurology

Mar 2024

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K233201 is an FDA 510(k) clearance for the MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter), a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on March 27, 2024, 181 days after receiving the submission on September 28, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K233201 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2023
Decision Date	March 27, 2024
Days to Decision	181 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