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These devices are intended for various non-permanent intravascular applications including pressure monitoring, fluid administration, and blood sampling.

The various SDM Central Venous Catheters consist of polyurethane bodies with zero to five polyurethane extension tubes. Except for the smallest French sizes of the single lumen devices, the catheters all contain an additional flexible polyurethane distal tip. The proximal end(s) of each catheter terminate in molded-on, fixed, female locking luers. Where present, the extension tubes are joined to the catheter body by insertmolded polyurethane and contain clamps for occluding the tubes. Many configurations are marked with centimeter markings to indicate insertion depth. Catheters will be offered in "kits" which will include some or all of the following depending on configuration: Catheter, guidewire in dispenser, dilator, syringe, scalpel, suture wing, and introducer needle. The makeup of specific sets can be seen in the Appendix D of this 510(k) submission. These kits will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids, or in standard Tyvek/Poly pouches, depending on the product configuration.

This device provides additional access ports into a standard angiographic fluid delivery system and can be used in conjunction with syringes and other accessories where angiographic injection is indicated. This product's medium/high nressure designation does not preclude its use for low pressure modalities.

The SDM Angiographic Manifold consist of one or more stopcocks, where the multiple stopcock configurations are connected in line to form a manifold, with some models of each also having a high pressure extension line attached. These devices have bodies made of nolvearbonate and handle plugs made of polyethylene. The plugs are lightlv siliconized for smooth rotation. Each of the devices will be supplied single packaged and sterile. Packaging will consist of a standard Tyvek/Poly pouch.

The intrauterine pressure monitoring catheter (IUP) is for use on patients requiring intrauterine monitoring, amniofusion, and sampling of amniotic fluid.

This 510(k) Notification is being submitted prior to marketing introduction of Scientific Device Manufacturer's Intrauterine Tip Transducer Catheter and its insertion device. Two models will be offered, one with a pressure transducer located at the proximal end using a fluid column to transmit pressure waves, the ther has the pressure transducer located in the distal tip. In both cases the transducer is a thick film/ceramic strain gage connected to a proximal connector interfaces with a reusable cable which is designed for proper connection to the monitor being used. Both devices will also have a separate fluid infusion and sampling lumen terminating in the side of the catheter near the distal end and integral to the connector at the proximal end. Incorporated in the tip transducer catheter is a signal interruption switch for electronic zeroing of the system following insertion and prior to commencement of use. This switch is also used for periodic rezeroing of the system during use without the need for removal and replacement of the catheter. Both catheter tips have rounded, blunt ends while the catheter material is soft, flexible polyurethane. This design minimizes the possibility of uterine perforation while at the same time providing maximum comfort for the patient. The catheter introducer, made of a somewhat stiffer polypropylene, is designed for easy insertion of the flexible catheter. It is of a split sheath design for simple removal following insertion. Also, a hook and loop attachment device is supplied for fixing the connector end of the catheter to the thigh following placement in order to prevent inadvertent dislodgement during use.

This device is intended for hand injection of contrast media during angiography.

The SDM Control Syringes consist of visibly clear high strength polycarbonate barrels, an elastomeric piston, and a high strength polymeric plunger terminating in a palm plate. The device is modeled in the European style in regard to the finger grips and palm plate. Each barrel is marked to 10cc's of volume in increments of 0.2cc and is very lightly coated with a medical grade silicone oil to enhance smootheness of operation. Two models will be available, one having a 0.5cc reservoir of internal volume remaining in the fully inserted position. The other model will leave no reservoir following full travel of plunger to the bottom of the barrel. These devices will be supplied single packaged and sterile. Packaging will consist of standard Tyvek/Poly pouches.

These devices are intended for use in percutaneous introduction of various catheters and/or guidewires into the vasculature.

The various SDM Percutaneous Catheter Introducer/Set range in dilator tubing sized from 4 Fr to 13 Fr and in dilator lengths from 100mm to 340mm. Sheaths paired with the dilators are tapered and close fitting to facilitate maximum ease of insertion. The sheaths are offered in both FEP and Pebax depending on customer preference. The sheath hemostasis valve contains a silicone seal and is offered both with a sideport and plain. An 18ga needle and guidewire of appropriate size will also be included with each set. Dilator luers are marked with a numeral and sheath caps are colored coded to indicate french size. These sets will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids. A more economical, reduced version of the set will also be offered containing just a dilator and sheath without hemostasis valve packaged in a Tyvek/Poly chevron pouch