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

    PORT-A-CATH ACCESS KIT

    K Number: K952201 · Decision Oct 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    13
    Review Days
    147

    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
    PORT-A-CATH ACCESS KIT
    K Number
    K952201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medi-Flex Hospital Products, Inc.
    Date Received
    May 10, 1995
    Decision Date
    October 4, 1995
    Product Code
    FMF
    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
    FMF Syringe, Piston

    Similar 510(k) Clearances

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

    Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Instylla Delivery Kit

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

    Other Clearances by Medi-Flex Hospital Products, Inc.

    K Number Device Name
    K970441 K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
    K962740 DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
    K952416 TRACHEOSTOMY CARE KIT
    K952256 PICC LINE KIT
    K952007 ADHEROL SEPP APPLICATOR
    K934790 SEPP ADHESIVE REMOVER
    K920399 COMPOUND BENZOIN TINCTURE USP FREPP
    K923516 COMPOUND BENZOIN TINCTURE USP SEPP
    K930196 CEPTI-SEAL I.V. PREP KIT
    K921347 CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER
    Search all 13 clearances from Medi-Flex Hospital Products, Inc. →