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510(k) Data Aggregation

    K Number
    K232752
    Device Name
    Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
    Manufacturer
    Jiangsu Vedkang Medical Science and Technology Co., Ltd.
    Date Cleared
    2024-02-26

    (171 days)

    Product Code
    GCA
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    GCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
    Device Description
    Stone Extraction Balloon is composed of balloon, radiopaque marker, catheter, handle, standard connector, two-way valve, support wire and inflators. Stone Extraction Balloon is operated by the inflation and deflation of balloon, as well as liquid is injection port to assist in imaging or flushing, and complete the removal of biliary calculus the endoscopic channel. The Stone Extraction Balloon is classified to different specifications according to the diameter of balloon and the liquid outlet. There are a total of 12 models, the largest balloon diameter is 20mm, the smallest balloon diameter is only 8.5mm, the operator can choose according to different clinical needs. EO sterilization and use for single use only.
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    K Number
    K212582
    Device Name
    SpyGlass Discover Balloon Dilation Catheter
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2022-05-06

    (263 days)

    Product Code
    GCA
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    GCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpyGlass Discover Balloon Dilation Catheter is indicated for laparoscopic and open surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.
    Device Description
    The SpyGlass Discover Balloon Dilation Catheter is a sterile, single use device. The device is a double-lumen catheter manufactured with a nylon copolymer shaft. The distal tip of the catheter consists of a NyBax™ balloon and is available in diameters of 6, 7, and 8 millimeters, and a length of 40 millimeters. The SpyGlass Discover Balloon Dilation Catheter accepts a 0.035-inch diameter guidewire.
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    K Number
    K210660
    Device Name
    Stone Retrieval Balloon Catheter
    Manufacturer
    Anrei Medical (Hangzhou) Co., Ltd.
    Date Cleared
    2021-04-27

    (54 days)

    Product Code
    GCA
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    GCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
    Device Description
    The Stone Retrieval Balloon Catheter is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some specifications, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some specifications, the balloon can be inflated to three sizes, 8.5mm, 12mm diameters, or 12mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with an outer diameter of 2.3mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end. It is used to insert the guide wire rapidly. EO sterilization and use for single use only.
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    K Number
    K200173
    Device Name
    Stone Retrieval Balloon
    Manufacturer
    Hangzhou AGS MedTech Co., Ltd.
    Date Cleared
    2020-05-01

    (99 days)

    Product Code
    GCA
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    GCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
    Device Description
    The subject Stone Retrieval Balloon is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some models, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some models, the balloon can be inflated to three sizes, 8.5 mm, 12 mm and 15 mm diameters, or 13mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with a outer diameter of 2.4mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. EO Sterilization and use for single use only.
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    K Number
    K200247
    Device Name
    Fusion Quattro Extraction Balloon
    Manufacturer
    Wilson-Cook Medical, Inc
    Date Cleared
    2020-02-27

    (27 days)

    Product Code
    GCA
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    GCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used for endoscopic removal of stones in the biliary system and for contrast injection.
    Device Description
    The subject device is composed of a latex balloon mounted at the distal end of a nylon triple lumen catheter. The balloon can be inflated to four sizes: 8.5 mm, 10 mm, and 15 mm diameters. Radiopaque bands are placed on the catheter to provide fluoroscopic visualization of the catheter and balloon location. The nylon catheter length is 200 cm with a diameter of 6.6 Fr. There is an injection port on the catheter either above the balloon or below the balloon depending on the device model. The catheter also has black ink markings for direct visualization.
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    K Number
    K193344
    Device Name
    Tri-Ex Extraction Balloon with Multiple Sizing
    Manufacturer
    Wilson-Cook Medical Inc.
    Date Cleared
    2019-12-13

    (10 days)

    Product Code
    GCA
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    GCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used for endoscopic removal of biliary stones and for contrast injection.
    Device Description
    The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three diameter sizes, 8.5 mm, 12 mm and 15 mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.
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    K Number
    K173659
    Device Name
    Howell D.A.S.H Extraction Balloon with Multiple Sizing
    Manufacturer
    Wilson-Cook Medical, Inc
    Date Cleared
    2018-07-06

    (219 days)

    Product Code
    GCA
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    GCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used for endoscopic removal of biliary stones and for contrast injection.
    Device Description
    The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. On the proximal end of the device, there is a blue handle with three ports that lead to the three internal lumens. On one side of the handle there is a leur lock injection port. In the center of the handle is the wire guide lumen port that is capped with a clear adapter. This clear adapter allows for contrast injection while the wire guide is in place. The remaining port is used for balloon inflation with a stopcock to control air movement in and out of the balloon. The balloon can be inflated to three sizes, 8.5 mm, 12 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter has a working length of 190cm. There are ink markings on the catheter for endoscopic visualization.
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    K Number
    K173414
    Device Name
    Advance Biliary Balloon Catheter
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-06-22

    (233 days)

    Product Code
    GCA
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    GCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Advance Biliary Balloon Catheter is indicated for laparoscopic and general surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.
    Device Description
    The Advance Biliary Balloon Catheter is a sterile, one-time use, device. The device is a doublelumen catheter manufactured with a nylon shaft. The distal tip of the catheter consists of a nylon balloon and is available in diameters of 6 and 8 millimeters, and a length of 4.0 centimeters. The Advance Biliary Balloon Catheter accepts a 0.035-inch diameter wire guide.
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    K Number
    K170292
    Device Name
    Tri-Ex Extraction Balloon With Multiple Sizing
    Manufacturer
    WILSON-COOK MEDICAL, INC
    Date Cleared
    2017-09-20

    (232 days)

    Product Code
    GCA
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    GCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used for endoscopic removal of biliary stones and contrast injection.
    Device Description
    The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three sizes, 8.5 mm, 12 mm and 15 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens corresponds to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.
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    K Number
    K063677
    Device Name
    FUSION QUATTRO EXTRACTION BALLOON XL
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Date Cleared
    2007-01-05

    (25 days)

    Product Code
    GCA
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    GCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for endoscopic removal of stones in the biliary system and for contrast injection.
    Device Description
    The subject extraction balloon represents modifications made to existing extraction balloons currently marketed by Cook Endoscopy. The Fusion Quattro Extraction Balloon XL is supplied sterile and intended for single use only.
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