OTW balloon dilatation catheter.
Product performance structure and composition of the catheter standard usable length of 138cm, by an internal axis and an external axis constitute a *** axis structure, its internal axis and external axis between the presence of annular gap for balloon expansion and suction deflated, the internal axis of the cavity in the insertion of angioplasty used for the introduction of the wire, the distal end of the Pebax balloon, with impermeable X-ray markings.
Registration No. State Drug Administration Equipment (into) word 2002 No. 3771338 product scope of application is suitable for coronary artery stenosis or bypass graft stenosis for balloon dilatation, in order to improve myocardial perfusion. Product name (Chinese) StormerOTW balloon dilatation catheter.
This product is an OTW type balloon dilatation catheter, which is divided into proximal and distal parts. The proximal portion of the catheter consists of an outer push rod and an inner push rod, and the proximal portion is bonded to a luer connector; the distal portion of the catheter consists of a Pebax 6333 head end, a Pellethane 2363 balloon, a Pebax 7233 outer push rod, and a triple-layered inner push rod, which is coated with a radiopaque marking band, and the balloon and distal portion of the catheter are coated with hydrophilic coatings; and it has an axial rod marking for intravascular localization in the lumina of brachial arteries and femoral arteries. Axial rod markers. Ethylene oxide sterilized for single use.
Generic name: OTW balloon dilatation catheter.
Trade name: Sprinter Legend.
English name: Sprinter Legend Over-The-Wire Balloon Dilatation Catheter.
Hanyu Pinyin: OTWQiuNangKuoZhangDaoGuan.
Indications: This product is used for balloon dilatation of stenotic portions of coronary arteries or bypass grafts to improve myocardial perfusion.
Specifications: SPL12506WL, SPL12510WL, SPL12512WL, SPL12515WL, SPL12520WL.
Approval number: State Food and Drug Administration Measures (in) No. 3774665 of 2014.