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510(k) Data Aggregation

    K Number
    K182895
    Device Name
    Wilson-Cook Achalasia Balloon
    Manufacturer
    Wilson-Cook Medical, Inc
    Date Cleared
    2019-01-25

    (102 days)

    Product Code
    PID
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    PID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is used to dilate the lower esophageal sphincter in patients with Achalasia. This device is indicated for adult use only.
    Device Description
    The subject dilation balloon consists of an PET balloon attached to a 75 cm that is secured to a white Pebax Y junction with two extension lines leading with a wire guide hub and an inflation hub. The catheter has four black ink markers on the catheter. The dilation balloon is composed of PET, with a patient contacting length of 8 cm which can be inflated to a single size of 30 mm or 35 mm in diameter. The balloon has a 1.16" long tip made of white Neuthane. Three tantalum radiopaque bands are placed underneath the balloon to assist in fluoroscopic visualization of the balloon.
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    K Number
    K132337
    Device Name
    ESOFLIP BALLOON DILATION CATHETER
    Manufacturer
    CROSPON, LTD.
    Date Cleared
    2013-10-07

    (73 days)

    Product Code
    PID, PIE
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    PID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EsoFLIP® Balloon Dilation Catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia.
    Device Description
    The EsoFLIP® balloon dilation catheter is a modification of the predicate Crospon EndoFLIP® catheters. The EsoFLIP® is a small catheter with an inflatable balloon which is inserted into the gastro-esophageal junction of a patient with Achalasia. It is connected to the EndoFLIP® controller system (K I20997) and the catherer is attached to a syringe, pre-filled with a diluted saline solution, which is inserted into the syringe pump on the front of the EndoFLIP® system. The EsoFLIP® catheter is inserted by the clinician. The proposed balloon dilation catheter, EsoFLIP®, can also make diameter measurements electrically using the same impedance planimetry measuring technique as that deployed in the predicate EndoFLIP® system. K 120997.
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    K Number
    K050232
    Device Name
    RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2005-03-11

    (38 days)

    Product Code
    PID
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    PID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boston Scientific Corporation Rigiflex™ II Single-Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
    Device Description
    The Rigiflex™ II Single-Use Achalasia Balloon Dilator consists of a balloon, catheter shaft, distal tip and proximal end.
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