FLOWRUNNER Aspiration System

The FLOWRUNNER Aspiration System is a peripheral thrombectomy device designed to remove fresh, soft blood clots (emboli and thrombi) from arteries and veins using aspiration through a catheter-based system. It consists of an aspiration catheter, sheath, vacuum fitting, stopcock connector, hemostatic valve connector, and hand actuator clip that work together to aspirate clots from occluded vessels.

The device extends the predicate product family to include smaller 7F and SP 7F diameter sizes (2.4 mm) in addition to the existing 12F and 14F sizes, with lengths from 60-130cm. Guide wire compatibility includes 0.014" for the 7F variants and 0.035" for larger sizes. All components use biocompatible materials, ethylene oxide sterilization, and maintain the same 13-month shelf life as the predicate.

The document references ISO 13485 standards for design controls (clause 7.3), nonconforming product handling (clause 8.3), and corrective/preventative actions (clause 8.5). Biocompatibility and package integrity testing were evaluated and leveraged from a prior submission (K234073). Not stated in this summary: specific ASTM or IEC standards for performance testing.

The FLOWRUNNER family is substantially equivalent because the smaller 7F and SP 7F sizes represent an extension of the already-cleared predicate device (K251488) with identical intended use, materials, design principles, and manufacturing processes. Bench testing including air/liquid leak resistance, catheter strength, fatigue, kink resistance, and dimensional inspections demonstrated no new safety or effectiveness concerns, supporting substantial equivalence.