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510(k) Data Aggregation

    K Number
    K251928

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-13

    (235 days)

    Product Code
    Regulation Number
    878.4350
    Age Range
    18 - 999
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CoolCryo cryoapplicator is a single use, sterile device indicated for the cryosurgical treatment for ablation of arrhythmic cardiac tissue by freezing target tissues, inducing an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.

    The CoolCryo cryoapplicator can be used in adults and is intended for use in the clinical environment by trained healthcare professionals.

    The CoolCryo control console is a nonsterile, reusable device which delivers cryogenic energy, namely liquid nitrogen, to the CoolCryo cyroapplicator. The CoolCryo control console can be used in adults and is intended for use in the clinical environment by trained healthcare professionals.

    Device Description

    The CoolCryo is a sterile, single-use cryogsurgical device to freeze target tissue, blocking electrical conduction pathways by creating an inflammatory response or cyronecrosis.

    The CoolCryo comprises a cryoapplicator and a control console with a liquid nitrogen reservoir:

    • CC01-01 Cryoapplicator for cardiac cryoablation,
    • CC01-21 Control console for cardiac cryoablation with liquid nitrogen reservoir.
    AI/ML Overview

    N/A

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