Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter

The Parafleet SC 014/018/035 PTA Balloon Dilatation Catheters are over-the-wire peripheral balloon catheters designed for percutaneous transluminal angioplasty (PTA). They dilate stenoses in iliac, femoral, popliteal, infrapopliteal, and renal arteries, treat obstructive lesions in arteriovenous dialysis fistulae, and enable stent post-deployment dilatation in peripheral vasculature. Available in working lengths of 40–200 cm with balloon diameters from 1.25–12.0 mm, they are sterilized with ethylene oxide for single use.

The devices feature semi-compliant balloon design compatible with 0.014, 0.018, and 0.035 inch guidewires and 4–7 French sheaths. Nominal pressure is 6 atm with rated burst pressure of 12–16 atm. Balloon length ranges 10–300 mm. Design elements include tip, marker bands, balloon, catheter shaft with similar materials and coating to predicates, and radio-detectability. The SC 035 variant has a tip similar (rather than identical) to the predicate.

Testing followed FDA guidance on Peripheral PTA and Specialty Catheters 510(k) submissions. Biocompatibility testing was conducted per ISO 10993-1 (biological evaluation of medical devices), including cytotoxicity, sensitization, systemic toxicity, hemocompatibility (hemolysis, thrombosis, complement activation), and pyrogenicity. Bench testing included dimensional verification, simulated use, balloon burst pressure, fatigue, compliance, and catheter body strength per these same industry standards.

The Parafleet catheters are substantially equivalent because they share identical principle of operation, mechanism of action, and intended use as the predicate Polux/Minerva/Atropos devices. Design and performance specifications are the same or similar: same guidewire sizes and sheath compatibility, same semi-compliant balloon type, same nominal pressure, comparable burst pressures and balloon dimensions, and identical sterilization method. Biological characteristics (materials, coating, tip design) are the same or substantially similar. All bench and biocompatibility test results met acceptance criteria and matched predicate performance, demonstrating the device design and construction are suitable for its intended peripheral vascular use.