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510(k) Data Aggregation
(205 days)
The Sprinter Legend RX and OTW 1.25mm Balloon Dilatation Catheter is indicated as a pre dilatation catheter for enlarging coronary luminal diameters during PCI procedures.
The Sprinter Legend RX 1.5-4.0mm balloon dilatation 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. The balloon dilatation catheter (balloon models 2.25 mm - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is a percutaneous transluminal coronary angioplasty (PTCA) device. The proximal end comprises of a luer hub, strain relief and a hypotube and stiffening wire subassembly (proximal shaft assembly). The distal end comprises of an inflatable balloon, dual lumen tip (guidewire lumen and the inflation lumen) and radiopaque marker bands. The distal shaft includes a hydrophilic coating to aid in device advancement to the target lesion. The guidewire lumen at the distal end enables the use of a 0.014" guidewire to position the device during use. Radiopaque balloon markers enable accurate placement at the target lesion. Exit markers on the proximal shaft indicate the exit of the balloon tip out of the guide catheter for brachial and femoral approaches.
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