Singapore - engelska - HSA (Health Sciences Authority)

abbott medical (singapore), pte. ltd. - cardiovascular - the brk transseptal needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

Singapore - engelska - HSA (Health Sciences Authority)

abbott medical (singapore), pte. ltd. - cardiovascular - the abbott medical transseptal catheter introducer set is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Singapore - engelska - HSA (Health Sciences Authority)

abbott medical (singapore), pte. ltd. - cardiovascular - fast-cath guiding transseptal introducers are indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

abbott medical australia pty ltd - 45418 - cardiac occluder - a self-expanding nitinol mesh, double-disc occlusion device for use in atrial septal defects. the 2 discs are connected by a short waist with a waist diameter that corresponds to the atrial defect size. to increase its closing ability, the device is filled with polyester fabric that is securely sewn to each disc by a polyester thread. radiopaque marker bands at each end of the device provide visualization under fluoroscopy. the amplatzer septal occluder is a percutaneous, transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects (asds) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration. patients indicated for asd closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular (rv) volume overload (ie, 1.5:1 degree of left-to-right shunt or rv enlargement).

Australien - engelska - Department of Health (Therapeutic Goods Administration)

abbott medical australia pty ltd - 45418 - cardiac occluder - a self expandable, double disc device made from a nitinol wire mesh. the two discs are linked together by a short connecting waist. in order to increase its closing ability, the discs are filled with polyester fabric. the polyester fabric is securely sewn to each disc by polyester thread. the amplatzer cribriform occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multi-fenestrated (cribriform) atrial septal defects. patients indicated for asd closure have echocardiographic evidence of fenestrated ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (i.e., 1.5:1 degree of left to right shunt or rv enlargement).

Australien - engelska - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 41493 - intranasal splint, biodegradable - the entact septal stapler consists of resorbable fixation devices, which are delivered via a manual surgical stapler delivery system. each sterile, single patient use device contains eight entact staples for holding the septal tissues together during post-op healing. the entact staple is designed to resorb in about 3 to 6 weeks when used according to labeling. the entact septal stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 36079 - catheter introducer, haemostasis valve - pathbuilder transseptal guiding introducer is designed to introduce various cardiovascular catheters into each heart chamber for further electrophysiology operation. it is comprised of a sheath, a dilator and a guidewire. the sheath has a marker band on the tip to observe the position of catheter at any time, valves to provide hemostasis, and a three-way stopcock on its sideport that can be used for aspiration, fluid infusion, blood sampling and pressure monitoring. pathbuilder transseptal guiding introducer is indicated for introducing various cardiovascular catheters into the heart via femoral vein, including the left side of the heart through the interatrial septum, and when used with cardiovascular catheters, for assisting catheters in reaching the target site.

Singapore - engelska - HSA (Health Sciences Authority)

alcare pharmaceuticals pte ltd - cardiovascular - the steerable transseptal needle and its accessory piercing stylet are used in conjunction with a transseptal introducer to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

Singapore - engelska - HSA (Health Sciences Authority)

smith & nephew pte. limited - ear, nose & throat - the entact septal stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

abbott medical australia pty ltd - 47247 - transseptal access system - the fastcath duo and fastcath trio introducer is a sheath that facilitates the introduction of various cardiovascular devices into the chambers of the heart. intended to be used to introduce closed end catheters and electrodes into a vessel where minimizing blood loss is essential.