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The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.

The Arrow® Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The insertion device consists of a handle with an integral needle, a passivelyactivated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter. The catheter is advanced over the needle and threaded over a guide wire into a peripheral vessel. The catheter system consists of a catheter body, juncture hub, integrated extension tubing with Luer hub, vent plug to prevent blood leakage during insertion, and a clamp. The catheter is intended for short-term use to permit delivery of infusion therapies. infusion of blood and blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood. The Arrow Endurance Extended Dwell Peripheral Catheter System is available in single lumen, 18 ga. 20 ga. and 22 ga. configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").

The Arrow® Pressure Injectable Midline Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term (< 30 days) peripheral access to the venous therapy, blood sampling. infusion, and pressure injection of contrast media. The maximum pressure injector equipment used with the Arrow Antimicrobial and Antithrombogenic Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub. Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness was evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.

The Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is a single use catheter designed to provide short-term peripheral access to the venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue FlexTip (flexible distal tip). The catheter is available in 4.5 Fr. Single lumen and 5.5 Fr. Double lumen configurations with a usable catheter length of 15 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the entire internal fluid path of the device are treated with a Chlorhexidine-based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties. The catheters will be packaged sterile in kits that will include components to facilitate insertion. The Chlorag+ard technology that is incorporated in the modified device's physical design is the same as the reference device.

The ARROW FlexBlock Continuous Peripheral Nerve Block Kit/Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

The Arrow® FlexBlock® Continuous Peripheral Nerve Block Catheter Kit/Set features a wire reinforced, polyurethane body with centimeter markings to facilitate placement for continuous plexus and peripheral nerve blocks. The catheter includes a SnapLock™ adapter to enable infusion of medications, and a stylet for enhanced maneuverability. Procedural trays also include a stimulating or non-stimulating plexus block needle, and other procedural components.

The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.

The Arrow® Quickflash Arterial Catheterization Device, which is a sterile, single use arterial catheterization device, is designed to permit access to the peripheral arterial circulation or to other small vessels. The Arrow® Quickflash Arterial Catheterization Device is an all-in-one design consisting of a translucent polyurethane, radiopaque single lumen arterial catheter-over-needle device that includes a clear chamber as part of the needle hub which allows visualization of blood flashback. The needle has openings to enhance flashback visibility and the hub is connected proximally to a slotted housing that contains the integral spring wire guide. A handle projects through the slotted housing to permit the advancement of the spring wire guide through the introducer needle into the vessel. This design allows for quick and simple catheter insertion since all of the devices required for insertion are provided together. The Arrow Quickflash Arterial Catheterization Device is available with and without integrated molded suture wings in 20 gauge configurations with usable lengths of 3.81 cm (1 ½").

The Pressure Injectable PICC with Chlorag+ard Antithrombogenic Technology is indicated for shortterm or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injection equipment used with the pressure injectable PICC may not exceed 300 psi. Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test nethods and no correlation between these test methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffess for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catherer tip is in the desired location. The VPS System is indicated for use as alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseve is not obtained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The purpose of this premarket notification is to propose design and material modifications to the subject device: the Arrow Vascular Positioning System (VPS) stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS . The Arrow Vascular Positioning System (VPS) Stylet PLUS (hereafter referred to as Arrow VPS Stylet PLUS) is designed for use with a VPS Console to guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavo-atrial junction. The CG+ Arrow PICC powered by Arrow VPS Stylet PLUS provides the user with an Arrow VPS Stylet PLUS already loaded into a central catheter. (The Arrow VPS Stylet PLUS and the Arrow VPS Stylet PLUS included in the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS are exactly the same stylet.) The subject device, the Arrow VPS Stylet PLUS has the following characteristics: - 6 ft overall length - < 0.021" outer diameter over working length of polyimide with polytetrafluoroethylene ● (PTFE) - Intravascular electrocardiogram (ivECG) signal sensing consists of a platinumiridium (Pt/Ir) conductor band assembly - Doppler transducer connected to coaxial cable at the distal end - Coaxial cable and ivECG wire attached to connector at the proximal end to be plugged in ● to VPS Console or extension cable (that in turn connects to the VPS Console) - Tuohy-Borst adapter - . Marking accessory The Arrow VPS Stylet PLUS is for use in a hospital setting by trained clinicians. The Arrow VPS Stylet PLUS is the stylet portion of a vascular positioning system designed to be used with the VPS Console and a market-available catheter. The Arrow VPS Stylet PLUS body is a polyimide tube with a fluoropolymer (PTFE) coating. The tubing contains a Doppler sensor on a coaxial cable and an intravascular electrocardiogram (ivECG) signal sensing platinum-iridium (Pt/Ir) conductor band with an intermediate stainless steel cannula that is welded to the stainless steel ECG wire. The stainless steel portions of the ECG conductor are encased within the platinum-iridium band. The Doppler sensor and the only exposed portion of the ivECG, i.e. the platinum-iridium band, are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to be plugged into the VPS Console or to an extension cable (that in turn connects to the VPS Console). The CG+ Arrow PICC Powered by Arrow VPS Stylet PLUS is the Arrow VPS Stylet PLUS preloaded into a 4.5 Fr 1-Lumen, 5.5 Fr 2-Lumen, 40-55 cm pressure injectable Chlorag+ard Peripherally Inserted Central Catheter (PICC). The CG+ Arrow PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the iniection of contrast media. The external catheter body and the internal fluid path of the device are treated with Chlorag+ard, a Chlorhexidine-based coating technology.

The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.

The Arrow® Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The insertion device consists of an ergonomically designed handle with an integral echogenic needle with a passively-activated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter is advanced over the needle and threaded over a guidewire into a peripheral vessel. Throughout catheter insertion. blood is contained within the device to aid in prevention of blood exposure. The catheter system consists of a translucent radiopaque polyurethane catheter, a needle with openings to enhance flashback visibility, a seal in the catheter hub designed to reduce blood exposure, a stabilization with a strain relief nose designed to reduce kinking at the hub of the catheter, integrated extension tubing with Luer hub, vent plug to prevent blood from leaking out during insertion, and a clamp to eliminate blood exposure when the vent plug is removed and replaced with a mating Luer component such as an infusion set or Luer access device. The catheter is intended for short-term use (less than 30 days) to permit delivery of infusion therapies, infusion of blood and blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood. The Arrow Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 18, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").

The device is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, apheresis, rapid fluid administration, intravenous therapy, blood sampling, pressure injection of contrast media, and central venous pressure monitoring. The catheter may also be used in a variety of renal replacement therapies, such as hemofiltration and hemoperfusion. The catheter may be inserted into the jugular, subclavian, or femoral veins. The maximum pressure injection flow rate is 6 mL / sec.

The Multi-Lumen Acute Hemodialysis Catheter for High Volume (hereafter referred to as the 3-L AHDC) is a short-term, single use catheter designed to provide access to the central venous system in a healthcare facility environment. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in a 12 Fr. triple-lumen configuration with usable lengths of 16-25 cm. The catheters can be used for the injection of contrast media. The maximum recommended pressure injection flow rate is 6 mL/sec. The catheters are packaged sterile with various components to facilitate insertion.

The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.

The Arrow® Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The insertion device consists of an ergonomically designed handle with an integral echogenic needle with a passively-activated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter is advanced over the needle and threaded over a guide wire into a peripheral vessel. Throughout catheter insertion, blood is contained within the device to aid in prevention of blood exposure. The catheter system consists of a translucent radiopaque polyurethane catheter, a needle with openings to enhance flashback visibility, a seal in the catheter hub designed to reduce blood exposure, a stabilization platform with a strain relief nose designed to reduce kinking at the hub of the catheter, integrated extension tubing with Luer hub. vent plug to prevent blood from leaking out during insertion, and a clamp to eliminate blood exposure when the vent plug is removed and replaced with a mating Luer component such as an infusion set or Luer access device. The catheter is intended for short-term use (less than 30 days) to permit delivery of infusion therapies, infusion of blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood. The Arrow Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 20 gauge configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").

The Arrow® Pessure Injectable Jugalarian Central Catherer™ with Chlorag+ard Antimicrobial and Antithrombagenc Technology is indicated for short-tern access to the central venous system for intrasenous therapy. blood sampling, infusion, pressure injection of contrast media and allows for contrasion The maximum pressure of pressure injector quipment used with the Arrow Pressure Injectable 1900 psi. The marimum pressure injection 110ve rate for the specific lumen heing used for pressure injection is printed on the extension line hub. Chionageurd Technology treatment on the cathere of the cathere body as well as the entire fibid pathway of the catherer has been shown to be citective in reducing microbial colonization on cathers. Antimierobial cities were evaluated using in ritre and in rive and in rive and in rive and in rive and in rive methods and no correlation between these esting methods and clinical outcome has currently been assertained. It is not intended to be used for the treatment of existing infections. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheress for use in placement of the cather. intravascular espability for ECG devection and intravascular ultrasound for eatherer guiding and passioning. The VPS Stylet, when used with the VPS Console, provides real-time catherer information by using the patient's physiological (curdize clectrical activity and blow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The VPS System is indicated for use as an sherative method to Internation venus cather up placement confirmation in add patients when a steady Blue Bullseye is obtained, NOTE: IT's steady Blue Bullained, standard haspital proctive should be followed to confirm catherer tip location. Limiting but not contraindiented situations for this receivers where alterations of cardiae thythm change the presentation of the fwave as in atial fibrillation, arrial flutter severe achycardia and pacental venous catherization procedures performed through femoral or suphenous vein access which of the P-vave. In such patients, who are easily identifiable prior to central venous catheter insertion. the use of an additional method is required to confirm catherer tip location.

The CG+ Arrow JACC powered by Arrow VPS Stylet has the following characteristics: - . 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet - . 5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet - . 6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet The CG+ Arrow JACC powered by Arrow VPS Stylet is a CG+ Arrow JACC pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations. The CG+ Arrow JACC devices will also be provided in sterile kit configurations without the Arrow VPS Stylet preloaded in the catheter. The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for the 1-Lumen and 2-Lumen catheters and 6 mL/sec for the 3-Lumen catheter. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based coating technology. The Arrow VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet is designed to be compatible with any catheter with an inner luminal diameter of at least 0.021 inch.

The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.

The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is a single use introducer designed to facilitate insertion of a device into the vasculature. The Peel-Away Sheath/Dilator Introducer Assembly is a unit comprised of a peel-away sheath introducer and a dilator. The Peel-Away sheath has a non-tapered body with a tapered tip to provide a smooth transition from the dilator. The Peel-Away sheath is a radiopaque polyethylene extruded sheath body with a molded polyethylene hub. The hub is designed with wings and a thin-wall peel groove on both sides that facilitate splitting the hub and sheath after a catheter is placed through the sheath. The sheath hub is also designed to allow the dilator to lock into the sheath during the insertion procedure. The polyethylene dilator has a tapered tip and an ergonomic hub that locks into the sheath hub during the insertion procedure. The dilator hub also features a Luer lock connection on the proximal end. The Peel-Away sheath/dilator introducer is available in 3 Fr. - 7 Fr. configurations with usable lengths of 7 and 10 cm.