Cardiovascular Systems Incorporated

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Contact: Roger Hamilton
Web: http://www.csi360.com
E-Mail:
Address: 651 Campus Dr., Saint Paul, Minnesota 55112, USA
Phone: +1-(651)-259-1600 | Fax: +1-(612)-677-3355 | Map/Directions >>

Profile: Cardiovascular Systems Incorporated deals with development and commercialization of medical devices for treating peripheral arterial diseases. Our products include Diamondback 360® PAD system, Viperwire™, Viperslide™, Vipertrack™ and Vipercaddy™. The Diamondback 360® PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries, and stenotic material from artificial arteriovenous dialysis fistulae. The system is contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present. Our Viperwire Advance™ guide wires are to be used exclusively with the Diamondback 360® PAD system to enable optimal orbital gain and efficient differential sanding. The Viperslide™ is a lubricant designed to optimize the smooth operation of the Diamondback 360® PAD system. Our Vipertrack™ radio-opaque tape provides an extra measure for identifying vessel lesion lengths in the peripheral anatomy.

FDA Registration Number: 3004742232

4 Products/Services (Click for related suppliers)

• Atherectomy Peripheral Catheter (FDA Code: MCW / 870.4875)

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

• Guidewires

• Instrument Lubricants

• Ruler and Caliper (FDA Code: FTY / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.