Cleared Traditional

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD

K243432 · Brainlab AG · Radiology
Jul 2025
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K243432 is an FDA 510(k) clearance for the Vascular Navigation PAD 2.0; Navigation Software Vascular PAD, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on July 22, 2025, 259 days after receiving the submission on November 5, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K243432 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2024
Decision Date July 22, 2025
Days to Decision 259 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OWB — Interventional Fluoroscopic X-ray System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy

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