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

    V-CATH POLY PICC

    K Number: K071875 · Decision Nov 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    30
    Review Days
    122

    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
    V-CATH POLY PICC
    K Number
    K071875
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hdc Corp.
    Date Received
    July 6, 2007
    Decision Date
    November 5, 2007
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

    Similar 510(k) Clearances

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

    Neonav ECG Tip Location System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PM2™ System with ECGuide™ Connector

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PM2+ System and SmartPICC Stylet

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

    Other Clearances by Hdc Corp.

    K Number Device Name
    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
    K983916 V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)
    Search all 30 clearances from Hdc Corp. →