Profile: Terumo Cardiovascular Systems (TCVS) develops, manufactures and distributes medical devices for cardiac & vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring & vascular grafting. The Fresenius continuous autotransfusion system (C.A.T.S) salvages red blood cells for retransfusion. Its features are fast processing time and fast elimination. Our CDI™ blood parameter monitoring system 500 has features such as continuous measurements & calculations, in-line shunt sensor, color LCD display, integral printer and automated 2-point gas tonometered calibration.

The company was founded in 1921, has revenues of > USD 1 Billion, has ~500 employees. TYO:4543 (SEC Filings)

FDA Registration Number: 1212122

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• Aortic Arch Dilators

• Aortic Cannulae

• Aortic Perfusion Cannulae

• Arterial Cannulae

• Arterial Filters

• Arterial Line Cardiopulmonary Bypass Blood Filter (FDA Code: DTM / 870.4260) A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

• Arterial Perfusion Cannulae

• Bone Clamp (FDA Code: HXD / 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.

• Cardioplegia Cannulae

• Cardiopulmonary Bypass Accessories (FDA Code: KRI / 870.4200) Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment.

• Cardiopulmonary Bypass Adaptor (FDA Code: DTL / 870.4290) A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

• Cardiopulmonary Bypass Blood Reservoir (FDA Code: DTN / 870.4400) A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

• Cardiopulmonary Bypass Heat Exchanger (FDA Code: DTR / 870.4240) A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

• Cardiopulmonary Bypass On-Line Blood Gas Monitor (FDA Code: DRY / 870.4330) A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.

• Cardiopulmonary Bypass Oxygenator (FDA Code: DTZ / 870.4350) A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

• Cardiopulmonary Bypass Vascular Catheter (FDA Code: DWF / 870.4210) A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

• Cardiotomy Reservoirs

• Cardiovascular Cooling/Heating Systems

• Cardiovascular Procedure Kit (FDA Code: OEZ / 870.1200) An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• Cardiovascular Surgical Saw Blade (FDA Code: DWH / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• Centrifugal Pump System

• Continuous AutoTransfusion Systems

• Dilators, Vascular

• Disposable Surgical Drape (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Disposable Surgical Instrument (FDA Code: KDC / 878.4800)

• Endoscopic Vein Harvesting Systems

• Extravascular Blood Pressure Transducer (FDA Code: DRS / 870.2850) An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 878.4800)

• Heart Vent Catheters

• Intravenous Blood Flowmeter (FDA Code: DPW / 870.2100) A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

• Knitted Polyester Grafts

• Monitoring Systems

• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960) An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

• Non-Invasive Tubing (FDA Code: GAZ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Non-Roller Type Cardiopulmonary Bypass Blood Pump (FDA Code: KFM / 870.4360) A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.

• Oxygen Saturation Monitoring Systems

• Oxygenators

• Pediatric Urine Collector (FDA Code: KNX / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

• Pediatric Venous Cannulae

• Platelet Concentrate System

• Sterile Specimen Mailer and Storage Container (FDA Code: KDT / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Sterile Specimen Trap (FDA Code: BYZ / 880.6740)

• Sterile Surgical Drapes (FDA Code: KKX / 878.4370)

• Sterilization Tray

• Sterilization Wrap (FDA Code: FRG / 880.6850) A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

• Sternum Saws

• Suction Catheter and Tip (FDA Code: JOL / 880.6740)

• Surgical Drapes (FDA Code: KKX / 878.4370)

• Surgical Drapes & Packs (FDA Code: KKX / 878.4370)