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

    INSYTE INTRODUCER CATHETER

    K Number: K942045 · Decision Jan 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    25
    Review Days
    256

    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
    INSYTE INTRODUCER CATHETER
    K Number
    K942045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Vascular Access, Inc.
    Date Received
    April 28, 1994
    Decision Date
    January 9, 1995
    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 Becton Dickinson Vascular Access, Inc.

    K Number Device Name
    K971339 INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS
    K970259 E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET
    K964049 FIRST MIDCATH CATHETER WITH DUAL LUMENS
    K964048 FIRST MIDCATH CATHETER KIT
    K964050 FIRST MIDCATH CATHETER
    K954906 FIRST PICC INTRODUCER CATHETER
    K952757 ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER
    K952861 ANGIOCATH & INSYTE AUTOGUARD CATHETERS
    K952053 E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS
    K950301 ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS
    Search all 25 clearances from Becton Dickinson Vascular Access, Inc. →