Disa Medinotec · Class II · Cleared Mar 11, 2025
| K-number | K241562 |
| Device name | OutFlo Aortic Valve Dilatation Balloon Catheter |
| Applicant | Disa Medinotec |
| Product code | OZT |
| Device class | Class II |
| Decision date | Mar 11, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1255 |
The OutFlo Aortic Valve Dilatation Balloon Catheter is a sterile, single-use over-the-wire catheter with a cluster of parallel balloons at its distal end. It is indicated for balloon aortic valvuloplasty and is designed to provide outward radial force while creating inter-balloon spaces that allow blood flow through the valve, avoiding ventricular pressure buildup.
The OutFlo shares the same intended use, indications, target population, operating principle, and fundamental design with the predicate C.R. Bard True Flow device. Both are balloon aortic valvuloplasty catheters with the same sterility assurance level. Minor differences exist in specific design details, but these do not raise safety or effectiveness questions.
ISO 11135:2014 (EO sterilization validation); ISO 10993-7:2008 (ethylene oxide sterilization residuals); 21 CFR 870.1255(b)(3) and (b)(4) special controls for balloon aortic valvuloplasty catheters.
Substantial equivalence is based on identical indications for use and the same fundamental technology and operating principle as the predicate. Comprehensive bench testing (dimensional verification, inflation/deflation performance, burst pressure, radial strength, flow characteristics) and clinical data (98% procedural success rate, zero device-related MAEs in 40-subject multi-center study) demonstrate the device performs as intended and meets specifications, supporting equivalence despite minor design variations.
View the full FDA submission: accessdata.fda.gov