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The LARIAT® RS Suture Delivery Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.

The LARIAT® RS Suture Delivery Device is a one-piece, single-use suture delivery and deployment device with a pre-tied size "0" polyester suture loop that is pre-loaded on a retractable Delivery Snare on the distal end of the device. The pre-tied suture loop is held onto the Delivery Snare and allows for multiple opening and closings of the suture loop without release. Upon tightening of the suture loop, the suture is released from the Delivery Snare. An accessory lumen within the LARIAT RS device is designed for aspiration. flushing or to accommodate a guide wire of up to 0.035" diameter. The LARIAT RS device offers the additional feature of allowing the user to release the Delivery Snare from the tissue during device removal from the target location following suture deployment. The LARIAT RS device is compatible with access site diameters of 4.3mm and larger. The suture is itself a cleared medical device as a part of K021019.

The LARIAT® III Suture Delivery Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.

The LARIAT® III Suture Delivery Device is a one-piece, single-use suture delivery and deployment device with a pre-tied size "0" polyester suture loop that is pre-loaded on a retractable Delivery Snare on the distal end of the device. The pre-tied suture loop is held onto the Delivery Snare and allows for multiple opening and closings of the suture loop without release. Upon tightening of the suture loop, the suture is released from the Delivery Snare. An accessory lumen within the LARIAT III device is designed for aspiration and flushing. The LARIAT III device is compatible with access site diameters of 4.3mm and larger. The suture is itself a cleared medical device as a part of K021019.

The LARIAT II Suture Delivery Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.

The LARIAT II Suture Delivery Device is a one-piece, single-use suture delivery and deployment device with a pre-tied size 0 polyester suture loop that is pre-loaded on the device. A lumen within the LARIAT II is designed for aspiration, flushing during the delivery, capture or release of the LARIAT II Suture. The LARIAT II is packaged with a guide cannula and a dilator which may be used for guidance and placement of the LARIAT II, and a surgical blade which is used for cutting excess suture. The suture is itself a cleared medical device as a part of Pre-Market Notification K021019.

The FindrWIRZ System is intended for use in the cardiovascular system for introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. A FindrWIRZ may also be used to manipulate and or reposition another FindrWIRZ. The FindrWIRZ System is not intended for use in the coronary or cerebral vasculature.

The FindrWIRZ System consists of the following components: A 0.035" x 90 cm FindrWIRZ A 0.025" x 260 cm FindrWIRZ Guide wire introducer Torque device Each FindrWIRZ is configured with a tapered core wire and a distal coil, the 0.035 FindrWIRZ has a proximal PTFE jacket and both wires have a hydrophilic coating. The distal tip of each wire has an encapsulated magnet of opposite polarization which is used for proximity sensing and connection of the two guide wires to facilitate manipulation and positioning of each other. The FindrWIRZ System is sterilized with 100% ethylene oxide.

The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.

The Occlusion Balloon Catheter consists of a catheter shaft with two independent lumens upon which an expandable balloon material is bonded. The "Guide Wire" lumen extends the length of the catheter and is used for placement of guide wires and injection of contrast for angiographic visualization. The "Balloon" lumen is used to inflate and deflate the balloon. Radiopaque markers at the location of the balloon provide fluoroscopic visualization of balloon placement. The outer diameter of the catheter shaft is coated with a hydrophilic polymer that reduces friction during manipulation in the vessel.

The LARIAT Loop Applicator facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.

The LARIAT Loop Applicator is a one piece, single-use suture delivery and deployment device with a pre-tied polyester suture loop that is pre-loaded on the device. A central lumen within the LARIAT Loop Applicator is designed for aspiration and stabilization of tissue during the delivery of the LARIAT Suture Loop.