BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Reprocessed PentaRay Nav eco High-Density Mapping Catheter

    K Number: K201806 · Decision Jun 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    357

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Reprocessed PentaRay Nav eco High-Density Mapping Catheter
    K Number
    K201806
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterilmed Inc. (Johnson and Johnson)
    Date Received
    July 1, 2020
    Decision Date
    June 23, 2021
    Product Code
    MTD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MTD Catheter, Intracardiac Mapping, High-Density Array

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MTD), ordered by most recent decision date.

    OptiMap Catheter - 60mm (OPTI-CATH2-60)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptiMap Catheter - 50mm (OPTI-CATH2-50)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sphere-9Dx Diagnostic Catheter (AFR-00009)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ablacath™ Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all