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

    CHEMO-CATH INTRAPERITONEAL CATHETER

    K Number: K863819 · Decision Feb 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    47
    Applicant Total
    30
    Review Days
    127

    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
    CHEMO-CATH INTRAPERITONEAL CATHETER
    K Number
    K863819
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Hdc Corp.
    Date Received
    September 30, 1986
    Decision Date
    February 4, 1987
    Product Code
    FJS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FJS Catheter, Peritoneal, Long-Term Indwelling

    Similar 510(k) Clearances

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

    Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FALLER STYLET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FALLER TROCAR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VETA PERITONEAL DIALYSIS CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    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. →