OutFlo Aortic Valve Dilatation Balloon Catheter— 510(k) K241562

Name: FDA 510(k) clearance K241562
Creator: U.S. Food and Drug Administration
Published: 2025-03-11

Substantially Equivalent

Disa Medinotec

FDA 510(k) clearance K241562 for OutFlo Aortic Valve Dilatation Balloon Catheter, Substantially Equivalent on 2025-03-11. Applicant: Disa Medinotec. Device class: 2.

Clearance details

Applicant: Disa Medinotec
Product code: Code OZT
Device class: Class 2
Regulation: 21 CFR 870.1255
Advisory panel: Cardiovascular
Date received: 2024-05-31
Decision date: 2025-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Johannesburg, ZA

Download summary PDF View on FDA.gov ↗

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K253855 — KardiaPSI Balloon Catheter2026-05-06
K260437 — Valvuloplasty Balloon Catheter (ValvuloPro)2026-03-20
K240967 — ValvuloPro Valvuloplasty Balloon Catheter2024-07-31
K231814 — ValvuloPro Valvuloplasty Balloon Catheter2023-10-12
K220881 — INOUE BALLOON A2022-12-18

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K211894 — Trachealator2021-11-24

Adverse events under product code OZT

product code OZT

Death: 20
Other: 2
Total: 22

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.