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The Globe Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum.

The Globe® Introducer is a single use, ethylene oxide sterilized medical device used to facilitate percutaneous access to the vasculature and into the heart chambers. The device consists of a 16 Fr (5.3 mm) inner diameter (ID) steerable sheath with a hydrophilic coating, a dilator compatible with 0.89 mm (0.035 in) guidewires, and a dilator loader. The proximal end of the sheath includes a handle with an integrated steering knob for bidirectional deflection control of the sheath tip, a steering indicator, and a slider. The slider contains a loader connection port for the dilator loader and a compatible catheter loader. The slider provides a hemostatic seal and a saline flushing line with a standard Luer fitting stopcock, for air removal and management.

The FARADRIVE Sheath is intended for percutaneous catheter introduction into the chambers of the heart, including the left side of the heart through the interatrial septum.

The FARADRIVE Steerable Sheath is used to facilitate access to the vasculature and into the chambers of the heart. The handle is furnished with a rotating Actuator Knob that enables a single plane unidirectional deflection and has the ability to actively straighten the distal end of the FARADRIVE Steerable Sheath curve when rotated. The FARADRIVE Steerable Sheath includes an integral hemostasis valve to minimize blood loss or air ingress during catheter and dilator manipulation and a side flush line with three-way stopcock for blood aspiration, fluid infusion, blood sampling and pressure monitoring. The sheath also includes distal vent holes to facilitate aspiration and minimize cavitation. The supplied dilator is shaped to assist in facilitating vascular or chamber access when fully inserted into the sheath. The proximal end of the dilator includes a feature that will lock to the sheath hub when fully inserted.

POLARSHEATH Steerable Sheath 12F: The POLARSHEATH steerable sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart. POLARMAP Circular Mapping Catheter: The POLARMAP Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. POLARMAP EP Electrical Cable: The EP Electrical Cable is designed for use with the POLARMAP Mapping Catheter and the hospital EP recording system. The EP Electrical Cable connects the POLARMAP Mapping Catheter to the hospital EP recording system. Use of the EP Electrical Cable is optional. SMARTFREEZE ETS Cables: The Esophageal Temperature Sensor (ETS) Cable (model M004CRBS6310 or M004CRBS6320) is designed for use with the SMARTFREEZE Console and a general purpose series 400 temperature sensor. The ETS Cable is used to connect a general purpose series 400 temperature sensor to the ICB. Use of the ETS Cable is optional. The ETS Cable (CIRCA) (model M004CRBS6340) is designed for use with the SMARTFREEZE Console and the CIRCA S-CATH™ Esophageal Temperature Probe. The ETS Cable (CIRCA) is used to connect the CIRCA S-CATH™ Esophageal Temperature Probe to the ICB (Model M004CRBS4130 only). Use of the ETS Cable (CIRCA) is optional. NOTE: The role of esophageal temperature monitoring using this device in reducing the risk of cardiac cryoablation-related esophageal injury has not been established. The performance of the SMARTFREEZE ETS Cables and compatible temperature probe in detecting esophageal temperature changes as a result of energy delivery during cardiac cryoablation procedures has not been evaluated. SMARTFREEZE Pressure Sensor Cable: The Pressure Sensor Cable is designed for use with the SMARTFREEZE Console and the cryoablation balloon catheter. The Pressure Sensor Cable is used to connect an intravascular pressure transducer to the ICB to measure the ventricular pressure during ablation procedures to aid in determining vein occlusion. Use of the Pressure Sensor Cable is optional.

POLARSHEATH™ Steerable Sheath 12F: Single-use, steerable percutaneous introducer sheath designed for additional maneuverability of diagnostic and therapeutic catheters that are advanced through the POLARSHEATH™ Sheath and into cardiac chambers. POLARMAP™ Circular Mapping Catheter: Single-use, multi-electrode catheter designed to record intracardiac electrograms and provide pacing stimulation during electrophysiology procedures. POLARMAP™ EP Electrical Cable: Single-use electrical cable that connects the POLARMAP™ mapping catheter to the hospital EP recording system. SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: Re-usable cables used to connect a temperature probe to the Inter Connection Box (ICB); used for continuous temperature monitoring during ablation procedures (optional). SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable: Re-usable cables used to connect a temperature probe to the Inter Connection Box (ICB); used for continuous temperature monitoring during ablation procedures (optional). SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable: Re-usable cables used to connect a temperature probe to the Inter Connection Box (ICB); used for continuous temperature monitoring during ablation procedures (optional). SMARTFREEZE™ Pressure Sensor Cable: Re-usable cable that connects an intravascular pressure transducer to the ICB. The pressure sensor is used to measure the ventricular pressure during ablation procedures to aid in determining vein occlusion.

The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through interatrial septum.

The Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the left side of the heart through the interatrial septum. The Steerable Guide Catheter is provided EtO sterile and for single use only.

The AcQGuide® VUE Steerable Sheath with electrodes is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The AcQGuide® VUE deflection facilitates catheter positioning. The electrodes help facilitate visualization of the sheath when used with a compatible localization system, such as the AcQMap System.

The AcQGuide® VUE Steerable Sheath, Model 900201 is a single use, percutaneous catheter introducer designed to provide additional maneuverability to interventional catheters that are advanced through the sheath and into the right or left chambers of the heart. The distal portion of the sheath is comprised of a composite structured single lumen shaft. At the proximal end, an ergonomic handle provides torque and active deflection, a hemostasis valve allows safe introduction of an interventional catheter, and a side port provides access for aspiration, fluid flushes and fluid/medication infusions. There is a cable exiting from the handle of the sheath to provide connection for the distal electrodes. This cable terminates with four standard 2mm pins that are connected to the Auxiliary Interface Box or Auxiliary Catheter Cable of the AcQMap High Resolution Imaging and Mapping System, Model 900100 or 900000. The pin connections are assigned by the user for electrode identification (D1, 2, 3, 4) to the corresponding channel on the AcQMap System 900100. No designated order of pin connection is required. The AcQGuide® VUE Steerable Sheath includes a valve bypass tool as an optional accessory to facilitate the insertion of a loop or circular catheter. The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart. The dilator has a smooth tapered tip and provides a smooth transition to the round edge of the non-traumatic tip of the sheath. The dilator is able to track over a 0.035″ guidewire. The hub section is attached to the shaft. It is a standard female luer made of high-density polyethylene (HDPE) material. Some of the key design attributes of the Steerable Sheath include: - Deflectability - Hemostasis - Kink-resistance - Visibility under fluoroscopy - Easily flushed during the procedure - Single-handed operation - Biocompatible materials - Sterile, single use - Combined three-way stopcock

The AcQGuide MAX Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The AcQGuide MAX deflection facilitates catheter positioning.

The AcQGuide® MAX Steerable Sheath, Model 900200 is a single use, percutaneous catheter introducer designed to provide additional maneuverability to interventional catheters that are advanced through the sheath and into the right or left chambers of the heart. The distal portion of the sheath is comprised of a composite structured single lumen shaft. At the proximal end, an ergonomic handle provides torque and active deflection, a hemostasis valve allows safe introduction of an interventional catheter, and a side port provides access for aspiration, fluid flushes and fluid/medication infusions. The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart. The dilator has a smooth tapered tip and provides a smooth transition to the round edge of the non-traumatic tip of the sheath. The dilator is able to track over a 0.035″ guidewire. The hub section is attached to the shaft. It is a standard female luer made of high-density polyethylene (HDPE) material.

The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The FlexCath Advance Steerable Sheath and Dilator is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath Advance Steerable Sheath and Dilator can be deflected to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chamber of the heart. The sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This premarket notification presents proposed design and material changes to the hemostasis valve component, located within the handle section. Product performance requirement changes related to the updated hemostasis valve are also being implemented for the subject device. All other aspects of the device (overall design/technology, labeling, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance Steerable Sheath and Dilator cleared under K183174.

The Steerable Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The Steerable Introducer consists of a single use, bi-directional steerable sheath connected to a handle with steering controls, a hemostasis valve with side port and 3-way stopcock, a tapered dilator and compatible guidewire. The device is provided sterile in a sealed Tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire and includes a proximal hub with a female luer tapered fitting for flushing.

The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of 0.204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray that is individually pouched in a Tyvek/Nylon corner peel pouch, heat-sealed one time, and the single sealed pouch is placed into a cardboard nest and top-loading box.

The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

The FlexCath Advance Steerable Sheath is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath can be deflected to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chamber of the heart. The FlexCath Advance Steerable Sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This premarket notification presents proposed updates to the Instructions for Use (IFU) manual; changes resulting in the subject device are limited to these IFU updates only. All other aspects of the device (design/technology, performance specifications, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance originally cleared under K123591.