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

    ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL

    K Number: K974015 · Decision May 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    45
    Review Days
    208

    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
    ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
    K Number
    K974015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Davis & Geck, Inc.
    Date Received
    October 22, 1997
    Decision Date
    May 18, 1998
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

    Similar 510(k) Clearances

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

    Introcan Safety® Deep Access XL IV Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Insyte™ IV Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SURFLO Hybria Closed System Safety IV Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Polyshield Safety IV Catheters

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Saf-T-Intima™ Subcutaneous Catheter System

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Davis & Geck, Inc.

    K Number Device Name
    K982853 SILK SUTURE
    K981582 SURGILON, DERMALON, & OPHTHALON
    K980610 DEXON RAPID (DEXON R)
    K980062 MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE
    K973409 KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
    K970857 ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO
    K972139 ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
    K972566 DEXON VIOLET
    K962971 POLYPROPYLENE MESH (VARIOUS SIZES)
    K955722 FLEXON TEMPORARY CARDIAC PACER LEAD
    Search all 45 clearances from Davis & Geck, Inc. →