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

    V-CATH

    K Number: K964966 · Decision Mar 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    30
    Review Days
    84

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    Basic Information

    Device Name
    V-CATH
    K Number
    K964966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hdc Corp.
    Date Received
    December 11, 1996
    Decision Date
    March 5, 1997
    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

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    Other Clearances by Hdc Corp.

    K Number Device Name
    K071875 V-CATH POLY PICC
    K023342 NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG
    K033853 MODIFICATION TO V-CATH POLY PICC
    K032404 SELDINGER SAFETY NEEDLE INTRODUCER
    K022752 PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
    K022099 SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S
    K010425 EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
    K994059 CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
    K002770 IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10
    K983119 ENTERO-TEST HP, MODEL #102-01
    Search all 30 clearances from Hdc Corp. →