Search Results

The Aquadex FlexFlow® System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatic patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow system comprises the following components: - . Aquadex FlexFlow console, microprocessor-controlled - . Blood Circuit Set with integral hemofilter, disposable - . Venous access catheter The Aquadex FlexFlow console includes a blood pump, ultrafiltrate pump, control panel, weight scale, air detector, blood leak detector, electrical connectors for the circuit pressure sensors, and mechanical interfaces that hold the circuit in place. The console controls the rate at which the blood pump removes blood from the patient, and the clinician sets the maximum rate at which the ultrafiltrate pump extracts ultrafiltrate from the blood. Patient access is obtained either peripherally or through the central venous veins. Blood is withdrawn from a vein and passes through a withdrawal pressure sensor before entering the blood pump tubing loop. The rotating rollers propel the blood through the the air detector, then into the hemofilter before being returned to the patient. The console screen displays information to help the clinician prime, set up, and operate the system. All system alarm limits are set by the console. The Aquadex FlexFlow blood circuit is a preassembled, sterile (EtO), single-patient use set. There are two models of the blood circuit: A06162 and A06163. The blood circuit set A06162 consists of a filter, tubing, pressure sensors, connectors, pinch clamps, a priming spike, an ultrafiltrate connecting bag and data key. The blood circuit set A06163 has the same components, except that it also has an inline blood chamber for use in monitoring the patient's hematocrit (Hct) during therapy. CHF Solutions Inc. offers a dual lumen extended length catheter (dELC) for use with the Aquadex FlexFlow System. The catheter is a peripheral venous access device with stainless steel coil reinforcement. The venous access catheter was not reviewed in K192756 as it was already cleared for safe and effective use under K041791 with no changes since the original clearance affecting its safety and effectiveness.

The Aquadex FlexFlow™ System is indicated for: • Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and • Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

The Aquadex FlexFlow™ System is indicated for: • Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and • Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

The Aquadex FlexFlowTM System is indicated for: • Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and • Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

The Aquadex FlexFlow™ System is indicated for: • Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and • Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins. This 510(k) is to add an alternate blood pump circuit which has a standard male and female luer adapter just before the filter on the withdrawal line to allow the optional use of a blood chamber cuvette to interface with a stand alone Hct monitor.

The Aquadex System is indicated for: Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow™ System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

The 5.2F dELC catheter is a peripheral venous access catheter, inserted preferably in the basilic vein (arm) and antecubital region respectively and specifically for use with the Aquadex™ System 100 when the blood flow rate is set at ≤20ml/minute. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs. The Aquadex System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

The 5.2F dELC is a 16 gauge, polyurethane, dual lumen extended-length catheter. It is intended to provide short-term peripheral venous access to facilitate blood removal and return for the purposes of ultrafiltration. The catheter has a low profile, flexible hub with suture wings for securement to the skin. The dual lumen tubing in the proximal portion of the catheter shaft is a double-D configuration and is fused to a single lumen tube for the distal portion. The catheter shaft construction includes a 304 stainless steel coil to minimize kinking from bending. The blood is drawn up through the single lumen tubing, and infused back into the vessel through the short proximal dual lumen section of the catheter shaft. The catheter will connect directly to the UF circuit of the Aquadex System 100 to conduct blood to and from the patient for the purposes of ultrafiltration. The 5.2F dELC is compatible with the Aquadex System 100 which utilizes software allowing blood flow rate adjustment as this catheters' optimal blood flow rate is at ≤20ml/minute.

The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.

The Aquadex System 100 removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

The Dual Lumen ELC catheters are peripheral venous access catheters, inserted preferably in the basilic vein (arm) and antecubital region respectively, and specifically for use with the System 100. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs. The System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

The dELC is a 6 French, polyurethane, dual lumen extended-length catheter. It is intended to provide short-term peripheral venous access to facilitate blood removal and return for the purposes of ultrafiltration. The catheter has a low profile, flexible hub with suture wings for securement to the skin. The dual lumen tubing in the proximal portion of the catheter shaft is a double-D configuration and is bonded to a single lumen tube for the distal portion. The blood is drawn up through the single lumen tubing, and infused back into the vessel through the short proximal section of the catheter shaft. The catheter will connect directly to the UF circuit of the System 100 to conduct blood to and from the patient for the purposes of ultrafiltration.

1) The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload. 2) The dual lumen ultrafiltration catheter [A1537] is indicated for use in attaining short-term (less than 30 days) percutaneous vascular access of the central circulatory system for ultrafiltration with the System 100. 3) The catheter extension [A1513] mav also be used to connect commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits. 4) The System 100 S-100 console [A1100] may be used when either peripheral or central venous access is employed. 5) The UF 500 circuit [A1500 and A1550] may be used when either peripheral or central venous access is employed.

The System 100 Ultrafiltration Catheters are part of the fluid pathway and intended for blood withdrawal and infusion when repeat venous access over a period of ≤ 30 days is medically desired. Common medical practice is to exchange the catheter every seven days to minimize infection. The CVC catheter is percutaneously introduced into the subclavian vein or the internal jugular vein with the distal tip ending in the mid to lower superior vena cava. The proximal end with the proprietary connectors resides outside the body connecting to the withdrawal and infusion blood lines of the UF500 blood circuits which engages the System 100 pump console for ultrafiltration in patients with fluid overloaded. The catheter extension (A1513) may also be used to connect other commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits.