FlowGuide (FG60F); GuidionShort (GS60F)

FlowGuide (FG60F) and GuidionShort (GS60F) are rapid exchange guide extension catheters designed to be used with guide catheters to access coronary and peripheral blood vessels. They facilitate placement and exchange of guide wires and other interventional devices. The devices are contraindicated in vessels smaller than 2.5mm, neurovasculature, and the venous system.

Both devices are single-lumen rapid exchange catheters 150cm long with stainless-steel proximal shafts and distal polymer shafts with embedded stainless-steel coiling. FlowGuide includes 9 perfusion holes in the distal shaft (unique feature) and has a shorter 15cm distal shaft versus the predicate's 25cm. Both have hydrophilic coating, radiopaque markers, and are compatible with 6F guide catheters.

ISO 10993-1 biocompatibility standard covering cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility.

The devices are substantially equivalent because they perform the same intended function as the predicate (guide extension) with nearly identical design and specifications. The two technological differences—shorter distal shaft length and perfusion holes on FlowGuide—are known features previously evaluated in the reference device (TrapLiner) and met all performance test criteria without raising new safety or effectiveness questions. Comprehensive verification testing demonstrated acceptable performance across 18 parameters and biocompatibility requirements.