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The SilverHawk™-R Peripheral Plaque Excision System for Surgical Use is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary, carotid, iliac or renal vasculature.

The SilverHawk-R Peripheral Plaque Excision System for Surgical Use consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk-R Peripheral Catheter and SilverHawk Cutter Driver. The SilverHawk-R Peripheral Plaque Excision System for Surgical Use is provided sterile for single-use. The catheter is sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 108, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.

The Rinspirator is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary and peripheral vasculature.

The Rinspirator consists of a catheter and a hand-held unit with accessories. The Rinspirator Catheter is a multi-lumen, rail configuration catheter to dispense an infusible fluid. The central lumen of the catheter is used for aspiration. The Rinspirator is provided sterile for single-use. The system is sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The device is biocompatible per ISO-10993-1.

The SilverHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

The SilverHawk Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver. The SilverHawk Peripheral Plaque Excision System will be provided sterile for singleuse. The catheter will be sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 ". The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 10°, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.

The SilverHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature and is not intended for use in the coronary or carotid vasculature.

The SilverHawk Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver. The SilverHawk Peripheral Plaque Excision System will be provided sterile for single-use.

The ReFORM Peripheral Catheter System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

The ReFORM Peripheral Catheter System consists of two major components which are packaged separately but used together during atherectomy procedures. The two components are the ReFORM Peripheral Catheter and the ReFORM Cutter Driver. The ReFORM Peripheral Catheter is comprised of a long, low-profile shaft at the end of which is a small mechanical cutter. The catheter is a monorail design which allows a single operator to insert and remove the device from the patient while maintaining guidewire position. A Cutter Driver controls the actuation of the cutting element. Excision of atheroma from the vessel is accomplished by a small spinning cylindrical blade contained within a cylindrical housing. Once the catheter is tracked to the target lesion, the tip is deflected, moving the cutter against the lesion. As the cutting blade spins, the device is advanced through the lesion, "shaving" plaque from the vessel wall. As the tissue is cut, it enters the device through a small opening just distal to the blade and is captured in the catheter tip and removed from the patient. ReFORM Peripheral Catheters consist of a braided drive shaft inside a Pebax/Nylon outer shaft, connecting to the cylindrical cutter and cylindrical cutter housing. The soft, flexible tip also provides an area for tissue collection. At the end of each cutting pass, the cutter advances into the soft tip "packing" tissue into the nosecone. The cutter housing is radiopaque due to plating with platinum which allows it to serve as an angiographic marker for easy positioning of the cutter blade within the lesion. ReFORM Peripheral Catheter System configurations covered under the subject 510(k) Premarket Notification include 7 F and 8 F sheath compatible diameter catheters in lengths of 135 cm and110 cm respectively.