FDA Clears Teleflex's 150 | 合法醫療器材資訊網
July 29, 2014—Teleflex Incorporated announced that its subsidiary Hotspur Technologies, Inc. received US Food and Drug Administration 510(k) clearance to market the Arrow GPSCath balloon dilatation catheter, which is designed in a 150-cm length for use with 0.014-inch guidewires.
According to Teleflex, the Arrow GPSCath device enables a variety of peripheral vascular procedures to be performed below the knee with one dual-function catheter, potentially reducing procedure time, radiation dosage, and procedure cost. The Arrow GPSCath balloon dilatation catheter combines angioplasty with Hotspur’s VisioValve injection system, which enables physicians to perform below-the-knee angioplasty and inject fluids such as contrast media while maintaining guidewire position.
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