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510(k) Data Aggregation

    K Number
    K223189
    Device Name
    Firefighter™ NC Pro PTCA Balloon Catheter
    Date Cleared
    2023-07-21

    (282 days)

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

    Shanghai MicroPort Medical (Group) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Firefighter™ NC Pro PTCA Balloon Catheter is indicated to be used for: Balloon dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; Balloon dilatation of post-delivery expansion of balloon expandable stents (models 2.00-5.00mm).
    Device Description
    Firefighter™ NC Pro PTCA Balloon Catheter is a rapid exchange catheter, with a non-compliant balloon near the distal tip. Two radiopaque marker bands are located underneath the balloon and fixed on the inner lumen to position the balloon. The hydrophilic coating is located on the whole distal section to reduce friction and enhance the crossing capability. The effective length of the catheter is 145cm, the inner lumen of catheter permits the use of guide wire ≤ 0.014 inch (0.36mm). Firefighter™ NC Pro is available with balloon diameters of 2.00-5.50mm and balloon lengths of 6, 10, 15, 20, 25 and 30mm. 5F Guiding catheter is used for the delivery of Firefighter™ NC Pro with 2.00-4.00mm balloon diameter. 6F Guiding catheter is used for the delivery of Firefighter™ NC Pro with 4.50-5.50mm balloon diameter.
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    K Number
    K143160
    Device Name
    FOXTROT NC PTCA Balloon Catheter
    Date Cleared
    2015-03-05

    (122 days)

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

    SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FOXTROT™ NC PTCA Balloon Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. FOXTROT™ NC PTCA Balloon Catheters are also indicated for the post-delivery expansion of balloon expandable stents.
    Device Description
    The FOXTROT NC PTCA Balloon Catheter device is a sterile, single-use, rapid exchange percutaneous transluminal coronary angioplasty catheter. The design is an integrated shaft system with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. Two radiopaque markers aid in positioning the balloon catheter under fluoroscopy during the procedure. The distal portion of the shaft is coated with a hydrophilic coating to provide lubrication. The effective length of the FOXTROT NC device is 145 cm and it is compatible with a 0.014" guide wire. The FOXTROT NC PTCA balloon catheter is available with balloon diameters of 2.5-4.0 mm and balloon lengths of 10 mm and 15 mm.
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