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510(k) Data Aggregation

    K Number
    K972017
    Device Name
    BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
    Manufacturer
    MINNTECH CORP.
    Date Cleared
    1997-09-10

    (103 days)

    Product Code
    DTN
    Regulation Number
    870.4400
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Biocor SVR Softshell Venous Reservoir is indicated for use in procedures requiring the dynamic storage of blood when used with a membrane oxygenator during procedures up to 6 hours in duration.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device (Minntech Corporation's Biocor 200 Soft Shell Venous Reservoir), not a study report or a summary of acceptance criteria and performance data.

    Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance), ground truth, and training set information is not present in the provided text.

    The document only states that the device is "substantially equivalent" to predicate devices for its indicated use, which is for dynamic storage of blood when used with a membrane oxygenator during cardiopulmonary bypass procedures up to 6 hours in duration. The substantial equivalence determination is based on the general controls provisions of the Act and compliance with GMP requirements.

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