Cleared Traditional

OutFlo Aortic Valve Dilatation Balloon Catheter

K241562 · Disa Medinotec · Cardiovascular

Mar 2025

Decision

284d

Days

Class 2

Risk

About This 510(k) Submission

K241562 is an FDA 510(k) clearance for the OutFlo Aortic Valve Dilatation Balloon Catheter, a Balloon Aortic Valvuloplasty (Class II — Special Controls, product code OZT), submitted by Disa Medinotec (Johannesburg, ZA). The FDA issued a Cleared decision on March 11, 2025, 284 days after receiving the submission on May 31, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1255.

Submission Details

510(k) Number	K241562 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2024
Decision Date	March 11, 2025
Days to Decision	284 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	OZT — Balloon Aortic Valvuloplasty
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1255
Definition	A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve.