Search Results

For XTRA Collection sets: "The XTRA Autotransufion System (including the XTRA Collection sets) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: - Cardiovascular - Orthopedics - Thoracic - Transplant surgery - Emergency (Trauma) - Neurosurgery - Obstetrics and Gynecology - Urology" For XTRA Sequestration set X: "The XTRA Autotransufion System (including the XTRA Sequestration set X) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: - Cardiovascular - Orthopedics - Thoracic - Transplant surgery - Emergency (Trauma) - Neurosurgery - Obstetrics and Gynecology - Urology"

XTRA Sequestration set X: The XTRA Sequestration set X is a single use sterile device made of plastic materials (mainly PVC) and it should be used in combination with a Bowl set and the XTRA autologous blood separation equipment unit (XTRA Equipment) for preoperative sequestration, aimed at autotransfusion. The XTRA Sequestration set consists of a system of tubing lines and bags, the autologous blood is recovered from the patient through routine hemodilution techniques and it's mixing with an anticoagulant in a blood bag, when blood is sufficient to fill the bowl set blood processing starts in order to separate blood into red blood cells (RBC), platelet poor plasma (PPP) and concentrated platelets or platelet rich plasma (PRP). In the bowl, because of centrifuqal force the blood components are separated and the RBC. PPP and PRP are collected into collection bags while the undesired elements (lysed cells, residuals, water, etc.) are discarded into a waste bag. The blood processed and collected in the bags is then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product. The XTRA Sequestration set is a modified version of the disposable currently marketed in the XTRA autotransfusion system (K101586). XTRA Collection sets: The XTRA Collection sets are single use sterile devices made of plastic materials (mainly PVC) and they should be used in combination with the XTRA autologous blood separation equipment unit (XTRA Equipment) for intraoperative cell salvage and/or postoperative cell salvage, aimed at autotransfusion. The XTRA Collection sets consist of a blood collection reservoir, an aspiration and anticoagulation line, a vacuum extension line and a system of tubing lines, the autologous blood is collected from the field by mean of a vacuum source (vacuum pump provided into the equipment) into a blood collection reservoir and filtered to remove large clots, debris and microaggregate and blood defoaming. From the reservoir, the blood may be immediately used for direct administration to the patient in case of emergency, otherwise, the collected blood is processed with a Bowl set (wash set) and then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product. The XTRA Collection sets are a modified version of the disposables currently marketed in the XTRA autotransfusion system (K101586) and in the XRES/XRES 120um Blood Collection Reservoirs (K131103).

The Aventus Clot Management System is indicated for use with the Aventus Thrombectomy System for autologous blood transfusion.

The Aventus Clot Management System accessory allows for autologous injection of aspirated blood from the Aventus Thrombectomy System embolectomy procedure. The sterile, single-use Aventus Clot Management System is comprised of the following two components: - Aspiration Syringe - . Clot Canister The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister. The Clot Canister connects to the Aspiration Syringe via quick disconnect connector at the inlet port on the side of the Canister. The aspirant from the Aventus Thrombectomy System procedure is injected into the Clot Canister. The blood passes through the Clot Canister dual layer nominal 40u/200u polyester screen filter, filling a syringe pre-connected to the female luer lock that is positioned below the filter assembly. The clinician can then return the filtered blood back to the patient via a standard sterile syringe with a required suitable blood transfusion filter (not provided). The Clot Canister also has a flush port with a standard 3-way stopcock positioned above the filter assembly where an additional syringe can be attached to inject saline or air to assist in clot visualization without removing the lid.

The XTRA Autotransfusion System (including the XTRA bowl set) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: - Cardiovascular - Orthopedics - Thoracic - Transplant Surgery - Emergency (Trauma) - Neurosurgery - Obstetrics and gynecology - Urology

The XTRA Autotransfusion System (with XTRA Bowl Sets) are single use sterile devices made of plastic materials (mainly PVC) and they should be used in combination with the XTRA autologous blood separation equipment unit (XTRA Equipment) for preoperative sequestration, intraoperative cell salvage, and/or postoperative cell salvage, aimed at autotransfusion. The XTRA Autotransfusion System (with XTRA Bowl Sets) consist of a disposable bowl pre-connected with a system of tubing lines and bags, the autologous blood is collected from the field by mean of a vacuum source (vacuum pump provided into the equipment), then the blood is pumped with a roller pump (provided into the equipment) into the bowl separation chamber and centrifuged. Because of centrifugal force the blood components are separated and the RBC, PPP and PRP are collection bags while the undesired elements (lysed cells, residuals, water, etc.) are discarded into a waste bag. The blood processed and collected in the bags is then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product. The XTRA Autotransfusion System (with XTRA Bowl Sets) are a modified version of the disposables currently marketed in the XTRA autotransfusion system (K101586).

The FlowSaver Blood Return System is used with Inari Medical catheters and sheaths for autologous blood transfusion.

The FlowSaver Blood Return System accessory allows for autologous injection of aspirated blood from Inari Medical catheters and sheaths during embolectomy procedures by dual layer 40 µm/200 µm filtration to minimize intraprocedural blood loss.

The FlowSaver Blood Return System is used with Triever Catheters for autologous blood transfusion.

The FlowSaver Blood Return System accessory allows for autologous injection of aspirated blood from the FlowTriever Retrieval/Aspiration System embolectomy procedure by dual layer 40 µ/200 µ filtration to minimize intraprocedural blood loss.

The Haemonetics® Cell Saver® Elite®+ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping the processed red blood cells to a product bag. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, plasma product for reinfusion to the same patient within the recommended time of the American Association of Blood Banks (AABB), 9th Edition.

The subject of this Traditional 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System 7.3 (AQ) software update which allows users the ability to manually control the cell salvage procedure through manual mode, quick transfer and decreased minimum wash volume. The Cell Saver Elite/Elite+ System consists of a single use disposable set and reusable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite/Elite+ System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite+ System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

· Evacuate air and/or fluid from the chest cavity or mediastinum. · Help re-establish lung expansion and restore breathing dynamics. Chest Drain Auto transfusion (ATS) To facilitate collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in postoperative and trauma blood loss management.

Atrium's Auto transfusion (ATS) Chest Drains are sterile, single use, disposable devices that mimic a traditional "3 Bottle Systems". A closed thoracic drainage system (chest drain and catheter together) are used to restore the chest to a more normalized condition after surgery, trauma, or spontaneous need for air and/or fluid to be removed. The Auto transfusion (ATS) features of the drains facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

The HEMAFUSE™ System is indicated for the collection of whole blood shed during a surgical procedure in which blood can be collected from the surgical field during periods of significant hemorrhage for purpose of reinfusion. It should only be used when performing surgery in remote military and austere military environments, when other sources of blood or autotransfusion are unavailable or thought inadequate for the need. Each Hemafuse System unit is indicated for a period of use no greater than 5 minutes.

Not Found

The FlowSaver Blood Return System is used with Triever Catheters for autologous blood transfusion.

The FlowSaver Blood Return System accessory allows for autologous injection of aspirated blood from the FlowTriever Retrieval/Aspiration System embolectomy procedure. The sterile (EO), single use FlowSaver Blood Return System is comprised of 2 components: • FlowSaver Blood Filter • 60 cc Luer Lock Syringe The FlowSaver Blood Filter has a sideport with a female quick connector for connection to the 60 cc Large Bore Vacuum Syringe (provided with Triever Catheter). Another standard Luer lock 60 cc syringe (provided) is attached to the needleless valve integrated into the FlowSaver's cap. The aspirant from a Triever Catheter embolectomy procedure is injected into the FlowSaver Blood Filter. Blood passes through the FlowSaver's dual layer 40 μ/200 μ polyester screen filter, filling the 60 cc syringe pre-connected to the female Luer Lock that is integrated into the cap of the filter housing. The 60 cc syringe is disconnected and its contents are injected through a suitable transfusion filter (minimum requirement 40 micron filter) prior to immediately reinjecting collected blood through an access sheath or catheter. FlowSaver's threaded cap with filter may be detached allowing rinsing with saline to remove thrombus and permit re-use if another Triever aspiration is performed. The FlowSaver may be used for up to five filtrations.

The CATSmart System by Fresenius Kabi is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Rich Plasma (PRP).

The Fresenius Kabi CATSmart device is an intraoperative autotransfusion system for intra- and/or postoperative processing of blood lost through surgery or trauma. The CATSmart device operates on the principle of a continuous flow centrifuge, comparable to continuous systems for hemapheresis which, for decades, have been widely used in blood banks. In a typical CATSmart procedure, the shed blood, which is anticoagulated and collected in a sterile reservoir, is processed in a continuous washing process to obtain washed packed red cells for reinfusion to the patient. During this process all plasmatic and nonerythrocytic cellular components of the collected blood, and thus activated coagulation factors, products of fibrinolysis and cell trauma as well as the anticoagulant are removed. The packed red cells are collected in a reinfusion bag from which they can be reinfused to the patient via a transfusion set when needed. The system includes disposable sets and accessories previously cleared by FDA in respective 510(k)'s.