Cleared Special

VersaD Delivery Catheter

K251372 · Unity Medical, Inc. · Neurology
Oct 2025
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K251372 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 October 24, 2025, 175 days after receiving the submission on May 2, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K251372 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2025
Decision Date October 24, 2025
Days to Decision 175 days
Submission Type Special
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