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PressureWire™ is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

The PressureWire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire is available in two different lengths. The guidewire is uniquely paired with a specific connection cable for PressureWire Certus or with a specific transmitter for PressureWire Aeris (subject device). Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.

Pressure Wire™ is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

The subject device, PressureWire™ Aeris™, is a new version of the predicate device (K131452), with the same name. The PressureWire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire is available in two different lengths. The guidewire is uniquely paired with a specific connection cable for PressureWire Certus ( not subject device for this submission) or with a specific transmitter for PressureWire Aeris (subject device). Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.

PressureWire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

The modified PressureWire™ is essentially a modification of the previously cleared PressureWire™ (K113584). The subject device, The subject and predicate device, PressureWire is a 0.014" guidewire with an integrated sensor element at the tip to enable measurements of physiological parameters. The guidewire is uniquely paired with a specific connection cable for PressureWire Certus or with a specific transmitter for PressureWire Aeris. PressureWire is available in different lengths.

PressureWire Net is intended to condition physiological signals from measuring devices (PressureWire and an external pressure transducer), transmit and receive via radiofrequency, and reconditions the signals to its original format so that those can be displayed on and/or recorded in a receiving device (RadiAnalyzer Xpress or other Monitor systems). The physiological signals can also be distributed via cable. Indication for Use: PressureWire Net is indicated to condition a physiological signal from the cardiovascular system, transmit and receive via radiofrequency, and recondition the signal to its original format so that it can be displayed. The physiological signal can also be distributed via cable.

PressureWire Net is a radiofrequency physiological signal transmitter and receiver that is used for conditioning a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a host system. PressureWire Net receives signals from the manufacturer's PressureWire and from a standard external pressure transducer, and then transmits those signals to a host system for further calculation and presentation. The subject device expands the contact range to also include a standard USB connector.

FemoStop Femoral Compression System is indicated for use in the compression of the femoral artery or vein after vessel cannulation and in ultrasound-guided compression repair of a femoral artery pseudoaneurysm.

This combination of FemoStop™ Femoral Compression is called FemoStop™ Gold and consists of an arch with a sterile pneumatic pressure dome, an integrated pump with a digital manometer and a belt. The pressure dome, the vessel punp with a digital manometer and a belt. The pressure dome is placed over the vessel puncture site in the groin. The belt is placed around the patient. The dome applies mechanical pressure over the vessel puncture site to induce hemostasis. The dome pneumatic pressure in the dome in emiliate site to induce hemostasis. The pneumatic pressure in the dome is applica and regulated by a manual pump and displayed on a manometer. The arch and belt provide counter pressure for the dome.