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510(k) Data Aggregation

    K Number
    K242776
    Device Name
    LimFlow V-Ceiver
    Manufacturer
    LimFlow Inc.
    Date Cleared
    2025-02-14

    (154 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    MMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.
    Device Description
    The LimFlow V-Ceiver is a percutaneous snaring device with a luer on the proximal end and a snaring basket at the distal end. The basket is composed of nitinol for shape memory and visibility with radiopaque markers on either end of the basket for added visibility. The coaxial sheathing system is used to re-constrain the basket once a guide wire is captured.
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    K Number
    K241259
    Device Name
    Amplatz Goose Neck Snare Kit
    Manufacturer
    Medtronic, Inc.
    Date Cleared
    2024-06-03

    (28 days)

    Product Code
    MMX, DXE
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    MMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amplatz Goose Neck Snare kit is intended for use in the cardiovascular system to retrieve and manipulate foreign bodies.
    Device Description
    The Amplatz Goose Neck Snare kit (Snare device) contains the snare, snare catheter, snare introducer, and torque device. The snare is made of a nitinol cable and a gold-plated tungsten loop. The preformed snare loop can be introduced through catheters without risk of snare deformation because of the snare's superelastic construction. The snare catheter contains a platinum-iridium, radiopaque marker band.
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    K Number
    K232443
    Device Name
    Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
    Manufacturer
    Argon Medical Devices, Inc.
    Date Cleared
    2023-09-07

    (24 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    MMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended for the percutaneous removal of retrievable inferior vena cava (IVC) filters that are no longer medically required, via jugular approach.
    Device Description
    The Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are single use devices. The disposable system consists of: [A] 9F (ID) Inner Sheath, [B] 11F (ID) Outer Sheath, [C] 8F (OD) Dilator, [D] Hemostasis Valve with Sideport, [E] High Pressure Stopcock, [F] 7F [2.4mm] (OD) x 76cm Snare Catheter with Tuohy-Borst Y-Port Adapter, 20mm x 93cm Single-Loop Snare (fully expanded) or 30mm x 93cm Triple-Loop Snare (fully expanded) with Torque Handle. The snares have radiopaque loops and are preloaded in the snare catheter. The snare catheter, inner sheath, and outer sheath have a radiopaque marker band at the distal tip for enhanced fluoroscopic visualization.
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    K Number
    K222254
    Device Name
    Gunther Tulip Vena Cava Filter Retrieval Set
    Manufacturer
    Cook Incorporated
    Date Cleared
    2023-05-16

    (293 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    MMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
    Device Description
    The Günther Tulip Vena Cava Filter Retrieval Set is composed of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip to assist in positioning of the sheath. The Günther Tulip Vena Cava Filter Retrieval Set is intended to retrieve the implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. The Günther Tulip Vena Cava Filter Retrieval Set is a packaged, sterile device intended for single use.
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    K Number
    K222083
    Device Name
    LimFlow V-Ceiver
    Manufacturer
    LimFlow Inc.
    Date Cleared
    2022-08-09

    (25 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    MMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LimFlow V-Ceiver™ is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.
    Device Description
    The LimFlow V-Ceiver consists of an intravascular catheter which incorporates a nitinol basket (the "Snare") at its distal tip. The nitinol basket has an outer diameter of 6 mm. The catheter has a built-in coaxial sheathing system and incorporates radiopaque markers at the distal tip on either end of the basket for added visibility. The catheter if compatible with 4 Fr introducer sheaths and has a working length of 100 cm.
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    K Number
    K212988
    Device Name
    ONO Retrieval Device
    Manufacturer
    Onocor Vascular LLC
    Date Cleared
    2022-05-23

    (245 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    MMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Onocor ONO Retrieval device is indicated for use in the cardiovascular system to retrieve objects using minimally invasive surgical procedures include retrieval of intravascular foreign objects such as coils, balloons, catheters, guidewires and/or filters within the cardiovascular system. This device is not intended for use in the coronary arteries or neurovasculature.
    Device Description
    The ONO Retrieval device is constructed of 12 Fr stainless steel reinforced catheter, a series of braided nitinol loops forming a basket, a peel away sheath, inner catheter and stop-cocks. The peel away sheath is advanced to compress the nitinol basket for introduction and then removed. The ONO is compatible with up to a 7 Fr manipulation device or snare and with 12Fr to 26 Fr retrieval sheaths. The ONO has a working length of 86 cm.
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    K Number
    K213494
    Device Name
    Aveir Retrieval Catheter
    Manufacturer
    Abbott Medical
    Date Cleared
    2022-04-01

    (151 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    MMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aveir Retrieval Catheter is intended to be used in the peripheral vasculature and the cardiovascular system to retrieve and manipulate an Abbott Medical leadless pacemaker (LP). Retrieval and manipulation includes removing the LP from the heart or peripheral vasculature.
    Device Description
    The Aveir™ Retrieval Catheter, model LSCR111 comprised of a valve bypass tool, a steerable/deflectable catheter, an integrated guiding catheter with a protective sleeve, and a tri-loop snare, assembled into a single catheter. The tri-loop snare, secured to a shaft, is used to grasp the docking feature on the proximal end of an Abbott Medical Leadless Pacemaker (LP), mate the LP to the Retrieval Catheter, unscrew the LP and retrieve the LP, thereby removing the LP from the patient's heart or peripheral vasculature. The Retrieval Catheter is supplied in a sterile pouch (sterilized via ethylene oxide), is intended for single-use only, and may not be re-sterilized. This device is an accessory designed to be used with both the Aveir Leadless System and the previous Nanostim Leadless Pacemaker (LP), model number S1DLCP. The Nanostim LP device has not been manufactured or implanted since November 02, 2016. However, the Nanostim LP (model S1DLCP) is currently implanted in patients and in the event these devices need to be retrieved, the Aveir Retrieval Catheter can be used. The Aveir Retrieval Catheter is intended to be used to retrieve an LP and to be manipulated by a single operator that allows the operator to perform these actions: - . Advance the Retrieval Catheter from an access site in the groin (utilizing minimally invasive techniques) through the femoral vein into the heart. - Steer and position the snare towards the docking button of the LP. . - Snare the docking button of the LP. ● - Dock the Retrieval Catheter to the LP. - o Rotate the LP to unscrew the LP helix from the endocardium. - Protect the LP helix and electrode during retrieval. ● - Extract the LP through the access site in the groin. o Apart from the docking mechanism, the Retrieval Catheter and its control system (handle) have the same operating principle as a conventional steerable catheter and control system, while the snare mechanism and dimensions are similar to commercially available snares systems. The Retrieval Catheter is intended to be used with the compatible Aveir Introducer. The Retrieval Catheter effective length is 105 cm (41.3 in) and the snare loop inner diameter is 16.5mm (0.65 in). The technical details and materials used in this product can be found in the Instructions for Use.
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    K Number
    K200963
    Device Name
    Halo Single-Loop Microsnare Kit
    Manufacturer
    Argon Medical Devices, Inc.
    Date Cleared
    2021-01-05

    (270 days)

    Product Code
    MMX, DQY
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    MMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Halo™ Single-Loop Microsnare Kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
    Device Description
    Halo™ Single-Loop Microsnare Kit contains: (1) Microsnare, (1) Microsnare Catheter, (1) Introducer and (1) Torque Handle. The microsnare is constructed of a flexible and radiopaque loop. The pre-formed microsnare loop can be introduced through the microsnare catheter without risk of microsnare deformation because of the snare's super-elastic construction. The microsnare catheter is constructed of flexible tubing and contains a radiopaque marker band.
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    K Number
    K200268
    Device Name
    Halo™ Single-Loop Snare Kit
    Manufacturer
    Argon Medical Devices, Inc.
    Date Cleared
    2020-06-03

    (121 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    MMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Halo™ Single-Loop Snare Kit is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.
    Device Description
    Halo™ Single-Loop Snare Kit contains: (1) Snare, (1) Snare Catheter, (1) Introducer and (1) Torque Handle. The snare is constructed of a flexible and radiopaque loop. The pre-formed snare loop can be introduced through the snare catheter without risk of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of flexible tubing and contains a radiopaque marker band.
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    K Number
    K193507
    Device Name
    Merit ONE Snare System
    Manufacturer
    Merit Medical Systems, Inc.
    Date Cleared
    2020-01-17

    (30 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Product Code :

    MMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONE Snare endovascular snare system is intended for use in the coronary and peripheral vascular system or hollow viscous to retneve and manipulate foreign objects. Retrieval and manipulation procedures include indivelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veripouncture procedure assistance.
    Device Description
    The ONE Snare Endovascular Snare System is a snare system that is designed for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. The One Snare wire consists of a Nitinol core with a ground tapered distal section, a formed nitinol cable covered with a gold-plated tungsten coil. The formed cable with coil is attached to the core wire and then covered with a PTFE polymer sleeve. The wires are packaged with an introducer, torque device and guiding catheter – this makes up the “One Snare Endovascular Snare System”.
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