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

    MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039

    K Number: K070705 · Decision Nov 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    48
    Review Days
    261

    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
    MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
    K Number
    K070705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vygon Corp.
    Date Received
    March 14, 2007
    Decision Date
    November 30, 2007
    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 Vygon Corp.

    K Number Device Name
    K121105 NUTRISAFE 2 FEEDING TUBE
    K100163 NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
    K073493 HEPATOSTAT SET
    K061796 HEPATOSTAT SET, MODEL 760X
    K061250 MULTICATH EXPERT
    K060944 NUTRISAFE 2
    K062425 LIFECATH S PICC AND MIDLINE CATHETER
    K052564 VYGON LEADER-FLEX
    K052881 VYGON LATEX FREE BIONECTOR
    K051248 VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
    Search all 48 clearances from Vygon Corp. →