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

    Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing

    K Number: K243047 · Decision May 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    96
    Applicant Total
    5
    Review Days
    243

    Basic Information

    Device Name
    Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
    K Number
    K243047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imperative Care, Inc.
    Date Received
    September 27, 2024
    Decision Date
    May 28, 2025
    Product Code
    NRY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NRY Catheter, Thrombus Retriever

    Similar 510(k) Clearances

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

    Raptor Aspiration Catheter; Balt Aspiration Tubing Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APRO 45 Catheter and Alembic Aspiration Tubing

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APRO 55 Swift Catheter and Alembic Aspiration Tubing

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APRO 70 Swift Catheter and Alembic Aspiration Tubing

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

    Other Clearances by Imperative Care, Inc.

    K Number Device Name
    K250775 Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System
    K242672 Zoom System
    K240948 TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
    K233975 Zoom 6F Insert Catheters