Singapore - English - HSA (Health Sciences Authority)

terumo singapore pte ltd - cardiovascular - intended to be used for percutaneous transluminal coronary angioplasty (ptca) for the purpose of improving myocardial blood flow in the localized stenotic lesion of the coronary arteries.

Australia - English - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - the device is a non-compliant percutaneous transluminal coronary angioplasty (ptca) rapid exchange system that consists of an integrated shaft and a balloon at the distal end of the catheter. the proximal end of the catheter has a standard luer to inflate or deflate the balloon by contrast medium. the coaxial dual lumen distal shaft creates the rapid exchange capability. the balloon catheter is coated with hydrophilic coating. the firefighter nc ptca balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, and for balloon dilatation of a stent after implantation.

Singapore - English - HSA (Health Sciences Authority)

microport pte ltd - cardiovascular - firefighter is indicated for balloon dilatation of the stenotic portion of a coronary artery for the purpose of improving myocardial perfusion in patients with following coronary artery diseases: ⚫ angina pectoris (stable or unstable); ⚫ chronic myocardial infarction ⚫ one or more stenosis in one vessel; ⚫ multi-vessel stenosis ⚫ coronary artery re-stenosis after coronary artery bypass graft (cabg); ⚫ coronary artery re-stenosis after ptca; ⚫ protected left main coronary artery stenosis

Australia - English - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - the device is a semi-compliant percutaneous transluminal coronary angioplasty (ptca) rapid exchange system that consists of an integrated shaft and a balloon at the distal end of the catheter. the proximal end of the catheter has a standard luer to inflate or deflate the balloon by contrast medium. the coaxial dual lumen distal shaft creates the rapid exchange capability. the balloon catheter is coated with hydrophilic coating. firefighter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Singapore - English - HSA (Health Sciences Authority)

dolphin healthcare pte. ltd. - cardiovascular - the selution slr 014 ptca is intended for use as a percutaneous transluminal coronary angioplasty (ptca) balloon catheter to dilate de novo or restenotic coronary lesions, for the purpose of improving myocardial perfusion and decreasing the incidence of restenosis.

Singapore - English - HSA (Health Sciences Authority)

arqon pte. ltd. - cardiovascular - the ptca catheter cathy no. 4 is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis or the tibial anterior and posterior artery of the lower limb with a maximum lesion length of 45 mm.

Australia - English - Department of Health (Therapeutic Goods Administration)

bio-excel australia pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - raiden 3 is a rapid exchange percutaneous transluminal coronary angioplasty balloon dilatation catheter. the distal side of the catheter is equipped with a balloon inflation to a specific diameter and length at recommended pressures. radiopaque marker (s) allows for confirmation of balloon's position in patient vessel under high resolution fluoroscopy. the inner lumen of the catheter is used to facilitate passage of 0.014" guide-wire and the other lumen for inflation/deflation of the balloon. this product is intended to be used for dilating the stenosis lesion in the coronary artery when performing percutaneous transluminal coronary angioplasty (ptca).

Australia - English - Department of Health (Therapeutic Goods Administration)

bio-excel australia pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - ikazuchi zero is a rapid exchange percutaneous transluminal coronary angioplasty balloon dilatation catheter. the distal side of the catheter is equipped with a balloon inflatable to a specific diameter and length at recommended pressures. radiopague marker(s) allows for confirmation of balloon's position in the patient vessel under high resolution fluoroscopy. the inner lumen is used to facilitate passage of a 0.014" guide wire while the other lumen is used for inflation/deflation of balloon. this product is intended to be used for dilating the stenosis lesion in the coronary artery when performing percutaneous transluminal coronary angioplasty (ptca).

Singapore - English - HSA (Health Sciences Authority)

medtronic international, ltd. - cardiovascular - the prevail paclitaxel-coated ptca balloon catheter is intended for percutaneous transluminal coronary angioplasty (ptca) in the coronary arteries with a vessel diameter from 2.0 mm to 4.0 mm to treat de novo lesions, in-stent restenosis (isr), and small vessel disease (svd).

Australia - English - Department of Health (Therapeutic Goods Administration)

philips electronics australia ltd - 44088 - coronary angioplasty balloon catheter, cutting/scoring - the proximal end of the catheter is a common ptca catheter design comprising a hypotube connected to a plastic hub. the hub-hypotube contact area is supported by a relatively soft strain relief to avoid kinking. the hub is used to inflate the balloon and can be connected to a standard inflation device. the distal part of the catheter consists of a conventional nylon balloon and a laser-cut nitinol scoring element having three or more spiral struts that wrap around the balloon. the angiosculpt scoring balloon catheter is indicated for the treatment of a hemodynamically significant coronary artery stenosis, including in-stent restenosis