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The product (FineCross M3) is intended to be percutaneously into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.

FineCross M3 is a single use, ethylene oxide sterilized device that is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. FineCross M3 features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyester elastomer and an inner layer of polytetrafluoroethylene. The outer surface of the catheter is coated with hydrophilic polymer.

The Progreat is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Progreat should not be used in cerebral vessels.

The Progreat catheter consists of metal coil reinforced multi-layer polymer tubing with a hydrophilic coating. The guidewire is comprised of an alloy core wire with radiopaque marker and hydrophilic coating. The subject 2.4 Fr Progreat catheter and 0.018" guidewire will be marketed as a combined unit and will be an extension of the existing Progreat product family. The design and technological characteristics of the subject 2.4 Fr Progreat with 0.018" guidewire are identical to the predicate 2.7 Fr Progreat with 0.021" guidewire. The Progreat catheter is available with or without accessories. The accessories to the catheter are supplied in different configurations depending on the product code: - The Guidewire has a super-elastic alloy core and is surface coated with a hydrophilic polymer. - I The Inserter is used to assist the physician in the placement of the guidewire within the catheter. - I The Catheter Mandrel (stylet) is used in the shaping of the catheter for procedures that require a catheter with a tip configuration other than straight. - I The Syringe is used in the priming of the catheter. - . The Wire Stopper can be clipped onto the guide wire to adjust the length of the guidewire that extends past the catheter tip. - I The Catheter Stopper S can be clipped onto the catheter to adjust the insertion length of the catheter. - . The Y-connector can be used to connect a power injector unit to the end of the catheter for infusion of contrast media.

The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities.

The R2P SlenGuide is a single use, ethylene oxide sterilized device that is designed to perform as a guiding catheter for interventional procedures in the peripheral vasculature. It is packaged with a guiding catheter and an inner guide. The guiding catheter features a three-layer construction with a stainless steel mesh, polyamide elastomer, and polytetrafluoroethyelene. The distal end has a hydrophilic coating and a soft-tip visible under fluoroscopy. The inner guide is an accessory device made of polyester elastomer with a flexible distal portion containing tungsten, visible under fluoroscopy.