Cleared Traditional

V-DAC Catheter

K251097 · Vesalio, Inc. · Neurology

Jan 2026

Decision

271d

Days

Class 2

Risk

About This 510(k) Submission

K251097 is an FDA 510(k) clearance for the V-DAC Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Vesalio, Inc. (San Diego, US). The FDA issued a Cleared decision on January 6, 2026, 271 days after receiving the submission on April 10, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K251097 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2025
Decision Date	January 06, 2026
Days to Decision	271 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