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510(k) Data Aggregation

    K Number
    K242863
    Device Name
    Bioptimal Bipolar Pacing Catheter
    Manufacturer
    Bioptimal International Pte. Ltd.
    Date Cleared
    2025-06-15

    (268 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Product Code :

    LDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bioptimal Bipolar Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.
    Device Description
    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environment for the enclosed catheter, and hence prevents the contamination of a catheter as it is inserted into and withdrawn from a body cavity or lumen.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.
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    K Number
    K251186
    Device Name
    Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
    Manufacturer
    C. R. Bard, Inc.
    Date Cleared
    2025-05-15

    (29 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Product Code :

    LDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K241334
    Device Name
    Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,
    Manufacturer
    C. R. Bard, Inc.
    Date Cleared
    2025-01-31

    (266 days)

    Product Code
    LDF, DYB
    Regulation Number
    870.3680
    Why did this record match?
    Product Code :

    LDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K241199
    Device Name
    Rotatable Connector (5944RL)
    Manufacturer
    Shenzhen Launch Electrical Co. Ltd
    Date Cleared
    2025-01-23

    (268 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Product Code :

    LDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K242705
    Device Name
    Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
    Manufacturer
    Medtronic Inc
    Date Cleared
    2025-01-17

    (130 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Product Code :

    LDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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).
    Device Description
    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.
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    K Number
    K232261
    Device Name
    TME Temporary Myocardial Electrode
    Manufacturer
    Osypka AG
    Date Cleared
    2024-04-26

    (270 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Product Code :

    LDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K190716
    Device Name
    Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
    Manufacturer
    Medtronic
    Date Cleared
    2019-08-08

    (142 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Product Code :

    LDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 6491 Unipolar Pediatric Temporary Pacing Lead is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY. The Model 6492 Unipolar Temporary Atrial Pacing Lead is intended for temporary postsurgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY The Model 6494 Unipolar Temporary Myocardial Pacing wire is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY. The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.
    Device Description
    The Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for use in both the atrium and the ventricle. The unipolar lead is comprised of a lead body with the distal and proximal segment. The Model 6491 Unipolar Pediatric Temporary Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. A curved atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. The Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for use in the atrium. The unipolar lead is comprised of a lead body with distal and proximal segments. The Model 6492 Unipolar Temporary Atrial Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. The Medtronic Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for use in both the atrium and the ventricle. The two leads are comprised of a lead body with distal and proximal segment. The Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of two insulated multi-filament wire. At one end of each wire has been stripped to have an electrode surface. This surface area can partly or completely be used as an electrode. The stripped end terminates distally in an atraumatic myocardial curved needle. An atraumatic chest needle at the proximal end of the conductor wire permits running the pacing wire to exit through the chest wall. The Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for use in both the atrium and the ventricle. The bipolar lead is comprised of a lead body with distal and proximal segments which includes the integrated bifurcated proximal lead connection. The Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multifilament lead, which contains a distal, discrete, ring electrode, a discrete, tip electrode, and a coaxial conductor lead body. Each discrete electrode is crimped onto a conductor and terminates in an atraumatic myocardial curved needle. The curved needle is used to create a channel in the myocardium for embedding the electrodes. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. Terminated on the back of the chest needle are two breakaway connector pins, which provide an attachment to an external pulse generator.
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    K Number
    K173923
    Device Name
    Temporary Cardiac Pacing Wire
    Manufacturer
    Ethicon, Inc.
    Date Cleared
    2018-08-02

    (219 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Product Code :

    LDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temporary Cardiac Pacing Wire is intended for use in temporary epicardial cardiac pacing or monitoring and should be removed after temporary pacing has been discontinued.
    Device Description
    The Temporary Cardiac Pacing Wire is a sterile single-use product. Temporary cardiac pacing wires consist of the following configurations and optional accessories: 1. The monopolar leads consist of one insulated multifilament stainless steel conductor coated with colored polyethylene. 2. The intracorporeal end of the wire has a section of exposed, uninsulated wire electrode which terminates with an attached stainless steel needle. 3. The exposed, uninsulated section of the intracorporeal end of the wire is either straight or has one or more multiple pre-formed curves (pre-formed wave). 4. The extracorporeal end of wire has a straight needle with breakaway tip attached. 5. The wire length is 60 cm. 6. Wires range in multiple diameters from 0 to 2-0, depending on the product code.
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    K Number
    K171253
    Device Name
    Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
    Manufacturer
    Medtronic
    Date Cleared
    2017-05-25

    (27 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Product Code :

    LDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary post-surgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY. The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary post-surgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY. The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary post-surgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less/ the device is supplied sterile and is intended for SINGLE USE ONLY. The Model 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary post-surgical pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY
    Device Description
    The Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for use in both the atrium and the ventricle. The unipolar lead is comprised of a lead body with the distal and proximal segment. The Model 6491 Unipolar Pediatric Temporary Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead remains in the body. The Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for use in the atrium. The unipolar lead is comprised of a lead body with distal and proximal segments. The Model 6492 Unipolar Temporary Atrial Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead remains in the body. The Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for use in both the atrium and the ventricle. The bipolar lead is comprised of a lead body with distal and proximal segments which includes the integrated bifurcated proximal lead connection. The Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multifilament lead, which contains a distal, discrete, ring electrode, a discrete, tip electrode, and a coaxial conductor lead body. Each discrete electrode is crimped onto a conductor and terminates in an atraumatic myocardial curved needle. The curved needle is used to create a channel in the myocardium for embedding the electrodes. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. Terminated on the back of the chest needle are two breakaway connector pins, which provide an attachment to an external pulse generator. No part of the Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Lead remains in the body. The Medtronic Model 6500 Unipolar Temporary Myocardial Pacing Lead is designed for use in both the atrium and the ventricle. The unipolar lead is comprised of a lead body with the distal and proximal segment. The Model 6500 Unipolar Temporary Myocardial Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body, except the silicone rubber disc in the case of atrial application.
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    K Number
    K161873
    Device Name
    Pacel Flow Directed Pacing Catheter
    Manufacturer
    St. Jude Medical
    Date Cleared
    2016-11-22

    (138 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Product Code :

    LDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pacel™ Flow Directed Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.
    Device Description
    This catheter is designed to establish temporary right ventricular pacing with or without fluoroscopy guidance for placement. Catheters are depth marked as an aid in catheter placement under fluoroscopy. Electrodes at the catheter tip enable ECG monitoring and bipolar pacing. An inflatable balloon, located between two platinum electrodes, allows for flow directed positioning of the catheter in the right ventricle without fluoroscopy guidance. Once inflated, the balloon aids the operator in crossing the tricuspid valve. After the catheter has crossed the valve, the balloon is deflated and the catheter is advanced to the right ventricular apex in the usual manner. Electrograms are monitored to verify proper positioning in the right ventricular apex and pacing thresholds are obtained to confirm both proper location and reliable pacing. The catheters are available in two curve styles. The distal end of the catheter includes a platinum electrical connector ring and a tip electrode. The proximal end of the catheter includes a two pin electrical connector. The electrical signals can be transmitted to external equipment or from external equipment to the heart.
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