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

    CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH

    K Number: K933050 · Decision Dec 14, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    51
    Review Days
    208

    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
    CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
    K Number
    K933050
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Critikon Company, LLC
    Date Received
    May 20, 1993
    Decision Date
    December 14, 1993
    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 Critikon Company, LLC

    K Number Device Name
    K002248 DINAMAP PRO 1000 MONITOR, MODEL 1000
    K000500 DINAMAP ADVANCED NIBP MODULE
    K992638 DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
    K982342 DINAMAP MPS SELECT PORTABLE MONITOR
    K943709 DINAMAP PLUS VITAL SIGNS MONOITOR
    K942700 DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340
    K933404 CRITIKON CENTRAL STATIN MONITOR
    K915697 CRITIKON VITAL SIGNS MODULE
    K921295 INTRAVENOUS CATHETERS MODIFICATIONS
    K912188 DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700
    Search all 51 clearances from Critikon Company, LLC →