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510(k) Data Aggregation

    K Number
    K964205
    Device Name
    BETTER-TUBING
    Manufacturer
    CIRCULATORY TECHNOLOGY, INC.
    Date Cleared
    1998-04-08

    (537 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K803277
    Why did this record match?
    Device Name :

    BETTER-TUBING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Better-Tubing™ is designed for use as a blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.

    Device Description

    The Better-Tubing™ (BT) is a 6 ft. length of ¼' ID tubing for use in an extracorporeal cardiopulmonary bypass circuit. It is biocompatible, has high tensile strength, and has many advantages over standard tubing made from polyvinyl chloride (PVC).

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Better-Tubing™ device, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / Performance ClaimBetter-Tubing™ Reported Performance
    BiocompatibilityPassed all ISO 10993 Part-1 Biocompatibility Tests (Intracutaneous Toxicity, Cytotoxicity, Sensitization, Systemic Toxicity, Genotoxicity, Implantation with Histopathology, Hemolysis, Whole Blood Coagulation Time, Pyrogenicity)
    Effect of Temperature on FlowMinimally affected by fluid temperature. Flow differed by no more than 3% at 22±2°C and 37±2°C.
    Hemolysis (compared to Tygon® tubing)Significantly less hemolytic than Tygon® tubing with standard occlusion (p
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