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510(k) Data Aggregation

    K Number
    K190619
    Device Name
    Aspiron(TM) Aspiration Catheter
    Manufacturer
    Meril Life Sciences Private Limited
    Date Cleared
    2019-04-29

    (49 days)

    Product Code
    QEZ
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meril Life Sciences Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aspiron(TM) Aspiration Catheter is used for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature system.
    Device Description
    The Aspiron™ Aspiration Catheter is a dual lumen, rapid exchange catheter consisting of a distal tip, distal shaft, and proximal shaft with luer hub at the proximal end. The smaller of the two lumens is the Guide wire lumen (distal tip) and is compatible with 0.014" (0.36mm) guide wires. The larger diameter lumen is the extraction lumen and when used with the Aspiron™ accessories, allows for removal of thrombus. The extraction lumen is provided pre-loaded with a stylet that resists kinking during delivery. A hydrophilic coating is applied to the distal shaft. The Aspiron™ is compatible with 6F guide catheters and has a working length of 140cm. The Aspiron™ accessories include 30ml suction syringes, a one way stopcock, an extension tube, a flushing needle and 70μm filter caps.
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    K Number
    K181023
    Device Name
    Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter
    Manufacturer
    Meril Life Sciences Private Limited
    Date Cleared
    2018-05-17

    (30 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meril Life Sciences Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mozec - Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm) is also indicated for post delivery expansion of balloon expandable stents. The Mozec NC – Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec NC - Rx PTCA Balloon Dilatation Catheter is also indicated for post delivery expansion of balloon expandable stents.
    Device Description
    Mozec - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a semi-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium marker(s) contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec balloon's working length (2.00 mm to 4.50 mm sizes) or the centre of the balloon's working length (1.50 mm size). The Mozec balloons are offered in diameters ranging from 1.50 mm to 4.50 mm and lengths varying from 9 mm to 41 mm. Mozec NC - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a non-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium marker(s) contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec NC balloon's working length. The Mozec NC balloons are offered in diameters ranging from 2.00 mm to 4.50 mm and lengths varying from 8 mm to 38 mm.
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    K Number
    K172737
    Device Name
    MESIRE - Balloon Sinus Dilatation System
    Manufacturer
    M/s. Meril Life Sciences Private Limited
    Date Cleared
    2017-12-12

    (92 days)

    Product Code
    LRC
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meril Life Sciences Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MESIRE™ - Balloon Sinus Dilatation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
    Device Description
    The MESIRE™ - Balloon Sinus Dilatation System consists of following components. It is available as an integrated system or individual components. - MESIRE™ Sinus Balloon Catheter - MESIRE™ Guide - Sinus Guide Catheter - MESIRE™ Illuminus Sinus Light Wire - MESIRE™ Latch Catheter Holding System
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    K Number
    K160961
    Device Name
    Mozec NC-Rx PTCA Baloon Dilatation Catheter
    Manufacturer
    MERIL LIFE SCIENCES PRIVATE LIMITED
    Date Cleared
    2016-07-30

    (116 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIL LIFE SCIENCES PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.
    Device Description
    Mozec™ NC - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a non-compliant balloon, a soft tip, a coaxial dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium markers contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec™ NC balloon's working length. The Mozec™ NC balloons are offered in diameters ranging from 2.00mm to 4.50mm and lengths varying from 8mm to 38mm.
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    K Number
    K131169
    Device Name
    MOZEC - RX PTCA BALLOON DILATATION CATHETER
    Manufacturer
    MERIL LIFE SCIENCES PRIVATE LIMITED
    Date Cleared
    2013-12-24

    (244 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIL LIFE SCIENCES PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mozec™ - Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec™ - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm to 4.50mm) is also indicated for post-delivery expansion of balloon expandable stents.
    Device Description
    Mozec™ - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a semi-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium marker(s) contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec ™ balloon's working length (2.00 mm to 4.50 mm sizes) or the center of the balloon's working length (1.50 mm size). The Mozec"™ balloons are offered in diameters ranging from 1.50mm to 4.50mm and lengths varying from 9mm to 41mm.
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