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Bioptimal Bipolar Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.

Bioptimal's Bipolar Pacing Catheter is made of radiopaque polyurethane catheter tubing at a usable length of 110 cm that allows the use of fluoroscopy for guiding the catheter during insertion or to verify its position when necessary. The catheter has radiopaque bands marked every 10 cm along their length to assist the physician in determining the depth of catheter insertion. The Bipolar Pacing Catheter has an electrode lumen, which provides electrical conductor isolation from electrodes to the connector pins. It has two metal electrodes attached to the distal end of the catheter and the distal electrode forms its distal tip. The proximal electrode is 10 mm apart from the distal electrode. Bipolar Pacing Catheters are available in two generic models: balloon-guided floatation (with balloon) and semi-floated (without balloon), with or without contamination shield. All models have the same basic design, construction and material. The balloon-guided models(BP2502-10 and BP2502CS-10) includes a latex balloon mounted between the distal and proximal electrodes and associated balloon lumen and tubing extension for inflating and deflating the balloon. The balloon is used for the advancement of the catheter tip by means of balloon flotation in the blood flow. The models with a contamination shield (BP2502CS-10 and BPX2502CS-10) have an expandable shield up to 110cm that provides a sterile environment for the enclosed catheter, and hence prevents the contamination of a catheter as it is inserted into and withdrawn from a body cavity or lumen. Balloon guided models are supplied with a 1.0cc syringe for balloon inflation. Bipolar Pacing Catheters are supplied sterile (through ethylene oxide sterilization), non-pyrogenic and are for single use only. The catheter primary packaging: the catheter is packed in a blue thermoformed polystyrene tray and is covered with a clear APET cover held in place by snap buttons. White label printed with the product name, model ID, manufacturer and authorized representative's information, lot number, expiry date, UDI, symbols and other product information is pasted on the clear APET tray cover. The catheter tray is placed inside a sealed Tyvek bag which forms a single sterile barrier primary packaging. The catheter is supplied sterile in a box of 5 units of single sterile barrier primary packaging with IFU.

Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device. The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

Bard® Temporary Pacing Electrode Catheters: Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device. Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device. Certain catheters may incorporate a lumen for balloon inflation. Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only. Needle / Cannula (Introducer): The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits. The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter. The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle is then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.

Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device. The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device. Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Pacing Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only. The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits. The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter. The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle in then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.

The rotatable connector is intended for use as part of a temporary cardiac pacing system. It connects a cardiovascular stimulating instrument to a cardiac pacing lead. It is intended for use by trained clinicians in a clinical environment.

The Model 5944RL rotatable connector is a pair of single use, disposable surgical cables with two adaptors. The cables are designed to connect a cardiovascular stimulating instrument to a cardiac pacing lead system.

Streamline temporary leads and wires treat an irregular heartbeat during or after cardiac surgery by providing electrical stimulation to the heart. - Models 6491, 6494, 6495, and 6500 are intended for atrial and ventricular use. - Model 6492 is intended for atrial use only. - Model 6491 and Model 6492 have smaller chest fixation coils and are appropriate for use in thin heart tissue and, in the case of Model 6491, a smaller chest cavity (for example, in a pediatric patient).

Each Streamline temporary pacing lead or wire comprises a lead body with a distal and a proximal segment. The distal segment has a separate electrode. A polypropylene monofilament (PP) fixation coil (except for model 6494) extends from the distal electrode end and is attached to a small, curved needle. The curved needle creates a channel in the myocardium for embedding the electrode. The PP fixation coil provides a means of securing the electrode in place. The proximal lead body terminates into a chest needle used to penetrate the chest wall, followed by pulling the proximal portion of the lead through the chest. The device is supplied sterile and intended for single use only.

The Swan-Ganz pacing-TD catheters are indicated for use for temporary, atrial, ventricular, or A-V sequential cardiac pacing of adult surgical and/or critically ill patients. This includes, but is not limited to, patients with arrythmias, acute myocardial infarction, cardiac surgery, and coronary angiography. In addition, these catheters are indicated for use in hemodynamic monitoring of patients experiencing medical conditions such as, but not limited to, post-major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, stroke, and cardiac disease including heart failure. The Swan-Ganz bipolar pacing catheters are indicated for use in surgical and/or critically ill cardiac patients who may benefit from temporary, transvenous right ventricular pacing. The Chandler transluminal V-pacing probe is a transluminal bipolar pacing probe, which must be used with a Swan-Ganz Paceport catheter is indicated for use in adult surgical and/or critically ill cardiac patients. This includes, but is not limited to, patients with arrhythmias, acute myocardial infarction, cardiac surgery and coronary angiography.

The Swan-Ganz Pacing Catheters and Pacing Probes are a series of specialized catheters and pacing probes, which are temporarily inserted into the central circulatory system vasculature to facilitate temporary atrial, ventricular, or A-V sequential pacing and to serve as diagnostic and/or therapeutic tools. The catheters may be used to overdrive suppression of arrhythmias and diagnosis of complex arrhythmias. The pacing catheters and probes may be used for ECG detection during placement but are not intended to be used for ECG monitoring.

The PacePro Wire is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures. Additionally, the PacePro Wire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.

The proposed PacePro Wire is a guidewire that includes functions for a structural wire and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either PacePro Wire or Opsens Pacing Wire (OPW). These two names are interchangeable and represent branding name vs. internal descriptive name.

OSYPKA TME Temporary Myocardial Electrodes are intended for temporary cardiac pacing and sensing of the cardiac chambers after cardiac surgery to prevent postoperative bradycardia and conduction disorders.

OSYPKA TME® temporary myocardial electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. The conductors or wires are typically 60cm or 220cm long and can be fixated to the heart either with the help of a suture (V-hook ), or directly with the attached heart needle (zigzag, and tines fixation types). The heart needle is cut off after fixation (Zigzag, Tines anchor) and disposed of. The thoracic needle is used to lead the wires to the outside of the patient's body to allow connection to the external pulse generator. The thoracic needle(s) is then also disposed of. OSYPKA TMEs are supplied as unipolar, bipolar, and quadripolar version. There are two options for connection to an external cardiac pacemaker or cable: with 2 mm adapter or Confix. The preassembled Confix connectors can be connected directly to an extension lead or to the cardiac pacemaker after the thorax needle has been cut off. The device is supplied sterile, non-pyrogenic and intended for single use only.

The NuCath™ Wedge Pressure Catheter is indicated for measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure).

The NuCath Wedge Pressure Catheter is an intravascular catheter with a balloon at the distal tip intended to measure pressure in the right heart.

The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the Savvy Wire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart. The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

The proposed SavvyWire™ is a new Catheter guidewire that includes functions for a structural wire, a pressure wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either SavvyWire™ or Opsens Structural Wire (OSW). These two names are interchangeable and represent branding name vs. internal descriptive name. SavvyWire™ is intended to be used with the OptoMonitor 3 (K202943), and ideally with the OpM3-DU TAVI, which is based on the approved OptoMonitor 3 (K202943), with a fully integrated TAVI software update.