Cleared Traditional

VersaD Delivery Catheter

K242051 · Unity Medical, Inc. · Neurology

Jan 2025

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K242051 is an FDA 510(k) clearance for the VersaD Delivery Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Unity Medical, Inc. (Edina, US). The FDA issued a Cleared decision on January 17, 2025, 189 days after receiving the submission on July 12, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K242051 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2024
Decision Date	January 17, 2025
Days to Decision	189 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