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

    QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+

    K Number: K061767 · Decision Jul 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    8
    Review Days
    26

    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
    QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
    K Number
    K061767
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Z-Medica Corporation
    Date Received
    June 23, 2006
    Decision Date
    July 19, 2006
    Product Code
    QSY
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

    Similar 510(k) Clearances

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

    BloodSTOP iX Trauma Matrix (TM-iX-20)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm

    FDA 510(k)
    FDA Unclassified ·Unknown

    MFUSE (MS001)

    FDA 510(k)
    FDA Unclassified ·Unknown

    TRAUMAGEL® 2.0 Hemostatic Gel

    FDA 510(k)
    FDA Unclassified ·Unknown

    TRAUMAGEL®

    FDA 510(k)
    FDA Unclassified ·Unknown

    Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Z-Medica Corporation

    K Number Device Name
    K120782 INTERVENTIONAL HEMOSTATIC BANDAGE
    K090620 QUIKCLOT INTEVENTIONAL, MODEL P/N 182
    K080247 QUIKCLOT NOSEBLEED
    K072474 QUIKCLOT EX
    K070010 QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER
    K051955 QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE
    K050769 QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172