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

    Vascu-Guard Vascular Repair Patch

    K Number: K221032 · Decision Oct 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    10
    Applicant Total
    9
    Review Days
    195

    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
    Vascu-Guard Vascular Repair Patch
    K Number
    K221032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synovis Life Technologies, Inc.
    Date Received
    April 7, 2022
    Decision Date
    October 19, 2022
    Product Code
    PSQ
    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
    PSQ Intracardiac Patch Or Pledget, Biologically Derived

    Similar 510(k) Clearances

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

    PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CardiaMend Pericardial and Epicardial Reconstruction Matrix

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADAPT Tissue

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XenoSure Biologic Patch

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MatriStem UBM Pericardial Patch

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PhotoFix Decellularized Bovine Pericardium

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

    Other Clearances by Synovis Life Technologies, Inc.

    K Number Device Name
    K223052 Peri-Guard and Supple Peri-Guard
    K221029 PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
    K143589 GEM Flow COUPLER Device and System
    K142447 PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch
    K142461 VASCU-GUARD Peripheral Vascular Patch
    K142309 GEM Flow COUPLER Device and System
    K132727 GEM FLOW COUPLER DEVICE AND SYSTEM
    K130896 VASCULAR PROBE, VASCULAR PROBE ES