DevicePMAs@therightstef:P080029_S000 JSONTXT 11 Projects

Approval for the quick-close vascular suturing system. this device is indicated as follows: the quick-close vascular suturing system is indicated to close femoral artery accesssites and to reduce time-to-hemostasis and time-to-ambulation in patients who haveundergone diagnostic or interventional endovascular procedures utilizing a 5, 6, 7, or 8french procedural sheath. additionally, the quick-close vascular suturing system is indicated to reduce time-to-hemostasis in patients who have undergone interventionalendovascular procedures utilizing a 5, 6, 7, or 8 french procedural sheath, who havereceived intraprocedural glycoprotein iib/iiia inhibitor therapy.