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

    ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER

    K Number: K030571 · Decision Mar 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    111
    Review Days
    32

    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
    ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER
    K Number
    K030571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ethicon Endo-Surgery, Inc.
    Date Received
    February 24, 2003
    Decision Date
    March 28, 2003
    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 Ethicon Endo-Surgery, Inc.

    K Number Device Name
    K141952 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
    K111195 VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
    K110385 ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
    K101520 ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
    K102632 ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
    K093896 ETHICON ENDO SURGERY SLOTTED ANOSCOPE
    K091259 ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
    K091824 ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
    K093236 ETHICON ENDO-SURGERYOPTICAL DILATOR
    K091290 ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
    Search all 111 clearances from Ethicon Endo-Surgery, Inc. →