Sangria™ Thrombectomy System

The Sangria™ Thrombectomy System is a sterile, single-use, 14 Fr catheter-based device designed to remove fresh, soft emboli and thrombi from peripheral venous vessels ≥7mm in diameter. It features a battery-operated handle with a rotational tip (200-270 rpm) that breaks down clots, which are then aspirated through the catheter lumen into an external collection canister via vacuum aspiration.

The Sangria uses mechanical maceration via rotating tip combined with aspiration, operating at 200-270 rpm with vacuum up to -250 mmHg and a 0.177" tip diameter. It differs from the predicate QuickClear (which uses aspiration alone without rotation) but shares similar over-the-wire design, 0.035" guidewire compatibility, 110cm working length, and continuous vacuum collection. The reference device Cleaner uses higher-speed rotation (4000 rpm) with a sinusoidal wire, whereas Sangria uses a deflectable spoon-shaped tip.

ISO 10993-1 (biocompatibility: cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility, thrombogenicity, complement activation, PTT, hemolysis, pyrogenicity); IEC 60601-1 and IEC 60601-2 (electrical safety and electromagnetic compatibility). Bench testing included dimensional/visual inspection, simulated use, kink resistance, corrosion resistance, tensile strength, torque strength, temperature rise, and run time.

The Sangria is substantially equivalent to the QuickClear predicate because both are Class II embolectomy catheters (21 CFR 870.5150) with identical indications for removing fresh, soft emboli and thrombi from peripheral venous systems using over-the-wire aspiration catheters. While Sangria adds rotational capability and uses different vacuum/tip specifications, it achieves the same mechanical thrombus removal function, passed equivalent non-clinical testing, and demonstrated biocompatibility and safety comparable to legally marketed predicates.