BTI IE15NT-14-3205-01
Description of goods
A VASCULAR SURGICAL DEVICE DESIGNED TO DELIVER POLYESTER SUTURE(S) TO CLOSE FEMORAL ARTERY PUNCTURE SITES FOLLOWING CATHERISATION PROCEDURE. THE DEVICE HAS TWO SUTURES AND FOUR NEEDLES. THE DEVICE CONSISTS OF A SHEATH, WHICH CONTAINS TWO PAIRS OF SUTURED NEEDLES, A NEEDLE GUIDE, WHICH PRECISELY CONTROLS THE NEEDLES AROUND THE PUNCTURE SITE AND A ROTATING BARREL WHICH RECEIVES DEPLOYED NEEDLES. THE DEVICE SHEATHS HAVE J-SHAPED TIPS AT THE DISTAL END. A MARKER LUMEN IS CONTAINED WITHIN THE BARREL OF THE DEVICE WITH THE INTRA-ARTERIAL PORT OF THE LUMEN POSITIONED IN THE NEEDLE GUIDE. PROXIMALLY, THE MARKER EXITS FROM THE HUB OF THE DEVICE. THE MARKER LUMEN ALLOWS A PATHWAY FOR BACK BLEEDING FROM THE FEMORAL ARTERY AND ENSURES PROPER DEVICE POSITIONING. THE BARREL ROTATES INDEPENDENTLY FROM THE CENTRAL CORE AND IS DESIGNED TO PROPARE THE SUBCUTANEOUS TRACK. BARREL ROTATION IS ACCOMPLISHED BY DEPRESSING THE INTERLOCKS EXITING THE HUB. THE DEVICES TRACK OVER 0.038” (OR SMALLER) GUIDE WIRE